Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Foil bags containing 2.2 lbs. each of almond flavored powder and sold under the Boba Direct, Inc. brand.
Bubble tea powders contain undeclared allergens.
Foil bags containing 2.2 lbs. each of avocado flavored powder and sold under the Boba Direct, Inc. brand.
Foil bags containing 2.2 lbs. each of banana flavored powder and sold under the Boba Direct, Inc. brand.
Foil bags containing 2.2 lbs. each of blueberry flavored powder and sold under the Boba Direct, Inc. brand.
Product code: BlueberryPwdr-BD; All lots
Foil bags containing 2.2 lbs. each of cafe latte flavored powder and sold under the Boba Direct, Inc. brand.
Product code: CafelattePwdr-BD; All lots
Foil bags containing 2.2 lbs. each of cherry flavored powder and sold under the Boba Direct, Inc. brand.
Foil bags containing 2.2 lbs. each of chocolate flavored powder and sold under the Boba Direct, Inc. brand.
Foil bags containing 2.2 lbs. each of coconut flavored powder and sold under the Boba Direct, Inc. brand.
Foil bags containing 2.2 lbs. each of honeydew flavored powder and sold under the Boba Direct, Inc. brand.
Foil bags containing 2.2 lbs. each of lavender flavored powder and sold under the Boba Direct, Inc. brand.
Foil bags containing 2.2 lbs. each of lychee flavored powder and sold under the Boba Direct, Inc. brand.
Foil bags containing 2.2 lbs. each of mango flavored powder and sold under the Boba Direct, Inc. brand.
Foil bags containing 2.2 lbs. each of matcha green tea flavored powder and sold under the Boba Direct, Inc. brand.
Foil bags containing 2.2 lbs. each of milk tea flavored powder and sold under the Boba Direct, Inc. brand.
Foil bags containing 2.2 lbs. each of passion fruit flavored powder and sold under the Boba Direct, Inc. brand.
Foil bags containing 2.2 lbs. each of peppermint flavored powder and sold under the Boba Direct, Inc. brand.
Foil bags containing 2.2 lbs. each of pineapple flavored powder and sold under the Boba Direct, Inc. brand.
Foil bags containing 2.2 lbs. each of red bean flavored powder and sold under the Boba Direct, Inc. brand.
Foil bags containing 2.2 lbs. each of strawberry flavored powder and sold under the Boba Direct, Inc. brand.
Foil bags containing 2.2 lbs. each of taro flavored powder and sold under the Boba Direct, Inc. brand.
Foil bags containing 2.2 lbs. each of vanilla flavored powder and sold under the Boba Direct, Inc. brand.
Foil bags containing 2.2 lbs. each of watermelon flavored powder and sold under the Boba Direct, Inc. brand.
Foil bags containing 2.2 lbs. each of spiced chai flavored powder and sold under the Boba Direct, Inc. brand.
Foil bags containing 2.2 lbs. each of green tea flavored powder and sold under the Boba Direct, Inc. brand.
SLIM-K, 30 Capsules, barcode 160126417509, Distributed by: Bethel Inc.
Marketed Without An Approved NDA/ANDA: Product was found to contain sibutramine, desmethylsibutramine and phenolphthalein based on FDA sampling and analysis.
The affected product was distributed to three consignees in Ohio, Utah, and Michigan.
Spicy Black Bean Burger powder mix, packaged in 30 LB poly-lined Kraft bags.
Undeclared peanuts in spicy black bean burger powder mix.
Cumin, Ground NET WT. 50 LBS. DISTRIBUTED BY: SOUTHERN STYLE SPICES PO BOX 20 MANOR, TX 78653 PHONE: (512)272-5621
The ground cumin may contain peanut protein.
distributed directly to Idaho, California, Oregon and Washington and in Ontario, Canada.
Ancho & Molasses Barbecue Sauce, Rub with Love brand, Net wt. 16 oz., UPC 6-72361-00044-1
Ancho & Molasses Barbecue Sauce, Rub with Love brand, containing ground cumin, is  recalled due to potential for contamination with peanut protein.
Chili Barbecue Sauce, Traeger brand, Net Wt. 12.9 oz. UPC 6-34868-91093-7
Chili Barbecue Sauce, Traeger brand, containing mild chili powder ingredient, is recalled due to potential for contamination with peanut protein.
Cilantro Salsa, All Natural Medium, Hazelwood's brand, Net Wt. 16 oz. (454 g), UPC 8-52707-00206-7
48 cases (6/16 oz bottles per case) and 3 bottles
Cilantro Salsa, All Natural Medium, Hazelwood's brand, containing ground cumin ingredient, is recalled due to potential for contamination with peanut protein.
Extra Spicy Stir Fry Marinade BBQ Sauce, the Hungry Dragon brand, Net Wt. 22 oz (623 g), UPC 7-01505-61996-5.   The label has the advisory statement: Produced in a facility that handles peanut, tree nuts, eggs, milk, wheat, and soy.
19 caes (12/22 oz. bottles per case) + 8 bottles
Extra Spicy Stir Fry Marinade BBQ Sauce, the Hungry Dragon brand, containing mild chili powder, is recalled due to potential for contamination with peanut protein.
Hot Pineapple Smash Salsa, Soog Head brand, Net Wt. 16 oz. (453 g), UPC 6-26570-62022-8
Best by Date: 4/8/2016 Lot code: 28114-8
22 cases (12/16 bottles per case) + 3 bottles
Hot Pineapple Smash Salsa, Soog Head brand, containing mild chili powder ingredient, is recalled due to potential for contamination with peanut protein.
Habanero Salsa, All Natural Hot, Hazelwood's brand, Net wt. 16 oz. (454 g), UPC 8-52707-00204-3
Best by Date: 7/2/2016 Lot code: 00215-6
Habanero Salsa, All Natural Hot, Hazelwood's brand, containing ground cumin and mild chili  powder ingredient, is recalled due to potential for contamination with peanut protein.
104 cases (12/16 oz. bottles per case) + 9 bottles
Hot Salsa, D.A.M. brand, containing ground cumin, is recalled due to potential for contamination with peanut protein.
Korma Simmer Sauce, Masala Maza brand, Net Wt. 12 oz. (340 g), UPC 6-48253-10101-5. The label has the advisory statement: Made in a facility that uses peanut, tree nut, egg, milk, wheat, and soybeans.
Korma Simmer Sauce, Masala Maza brand, containing ground cumin, is recalled due to potential for contamination with peanut protein.
Medium Pineapple Smash Salsa, Soog Head brand, Net Wt. 16 oz (453 g),  UPC 6-26570-62023-5
Best By Date: 4/8/2016 Lot code: 28114-7
Medium Pineapple Smash Salsa, Soog Head brand, containing mild chili powder ingredient, is recalled due to potential for contamination with peanut protein.
Mild Pineapple Smash Salsa, Soog Head brand, Net Wt. 16 oz (453 g), UPC 6-26570-62024-2
67 cases (12/16 oz. per case) + 1 bottle
Mild Pineapple Smash Salsa, Soog Head brand, containing mild chili powder ingredient, is recalled due to potential for contamination with peanut protein.
Medium Salsa, D.A.M brand, Net Wt. 16 oz (453 g), UPC 1-87283-00002-3
76 cases (12/16 oz. bottles per case) + 2 bottles
Medium Salsa, D.A.M brand, containing ground cumin ingredient, is recalled due to potential for contamination with peanut protein.
Mild Salsa, D.A.M brand, Net Wt. 16 oz (453 g), UPC 1-87283-00001-6
75 cases (12/16 oz. bottles per case) + 3 bottles
Mild Salsa, D.A.M brand, containing ground cumin, is recalled due to potential for contamination with peanut protein.
Spicy Maria Salsa, D.A.M. brand, Net Wt. 16 oz (453 g), UPC 1-87283-00003-0
24 cases (12/16 oz. bottles per case) + 9 bottles
Spicy Maria Salsa, D.A.M. brand, containing ground cumin ingredient, is recalled due to potential for contamination with peanut protein.
Salsa, All Natural Mild, Hazelwood's brand, Net Wt. 16 oz (453 g), UPC 8-52707-00202-9
149 cases (6/16 oz. bottles per case) + 2 bottles
Salsa, All Natural Mild, Hazelwood's brand, containing ground cumin and mild chili powder ingredients, is recalled due to potential for contamination with peanut protein.
Smoky Sweet Salsa, All Natural Medium, Hazelwood's brand, Net Wt. 16 oz (453 g), UPC 8-52707-00200-5
Smoky Sweet Salsa, All Natural Medium, Hazelwood's brand, containing ground cumin, is recalled due to potential for contamination with peanut protein.
Original Flavor Stir Fry Marinade BBQ Sauce, The Hungry Dragon brand, Net Wt. 22 oz (623 g), UPC 7-05105-61946-0   The label has the advisory statement: Produced in a facility that handles peanut, tree nuts, eggs, milk, wheat, and soy.
18 cases (12/22 oz. bottles per case) + 8 bottles
Original Flavor Stir Fry Marinade BBQ Sauce, The Hungry Dragon, containing mild chili powder, is recalled due to potential for contamination with peanut protein.
Mild BBQ Sauce, Ooga Booga brand, Net wt. 17. 6 oz (498 g), UPC 8-13012-00435-1
Lot Codes: 28614-6 and 34514-5 Best by dates: NONE
156 cases (12/17.6 oz. bottles per case)
Mild BBQ Sauce, Ooga Booga brand, containing ground cumin and mild chili powder, is recalled due to potential for contamination with peanut protein.
N'Between BBQ Sauce, Ooga Booga brand, Net wt. 17. 2 oz (498 g), UPC 8-13012-00437-5
Lot Codes: 28614-7; 34514-4; and  00715-8 Best by Dates: NONE
204 cases (12/17.2 oz. bottles per case)
N'Between BBQ Sauce, Ooga Booga brand, containing ground cumin and mild chili powder, is recalled due to potential for contamination with peanut protein.
Wild BBQ Sauce, Ooga Booga brand, Net wt. 17. 6 oz (498 g), UPC 8-13012-00436-8
Wild BBQ Sauce, Ooga Booga brand, containing ground cumin and mild chili powder, is recalled due to potential for contamination with peanut protein.
Oregon Microbrew BBQ Sauce, Paradigm and Fess Parker brand, net wt. 12 fl. oz. (343 mL).   The Paradigm has the UPC 0-37644-30520-8.  The Fess Parker brand does not have UPC.    The advisory statement on label is read ''Made in a facility that handles peanuts, tree nuts, eggs, milk, wheat, soybeans, and fish''.
47 cases (6/12 fl. oz. bottles per case)
Microbrew BBQ Sauce containing  mild chili powder, is recalled due to potential for contamination with peanut protein.
0.9% Sodium Chloride Injection, USP, in 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752-7925 for Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield, IL 60015-4625. NDC 0338-0049-02
Presence of Particulate Matter: Products recalled due to  presence of particulate matter (metal)
5% Dextrose Injection, USP, 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752-7925 for Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield, IL 60015-4625. NDC 0338-0017-02
10% Dextrose Injection, USP, 250mL  VIAFLEX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752-7925 for Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield, IL 60015-4625. NDC 0338-0023-02
Lactated Ringers Injection, USP, 250mL VIAFELX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752-7925 for Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield, IL 60015-4625. NDC 0338-0117-02
Lombart 90D Clear with case Visualization during diagnosis and laser therapy of the human retina (fundus) using a slit lamp.
Mislabeling.  The incorrect lot number was engraved on the anodized aluminum ring.  The correct lot number is BE03356; however, BD03356 was engraved on the ring in error.
New Punjab Burfi is an Indian snack cut into 1lb or 0.5 lb. squares. Product is packaged in clear plastic container with a clear plastic lid.
Company does not use a coding system to trace finished products.
This voluntary recall is being initiated because the following Indian snack may contain undeclared nuts (undeclared almonds, pistachios, and cashews):   New Punjab Burfi
New Punjab Kaju Katri is an Indian snack cut into squares. Product is packaged in clear plastic container with a clear plastic lid. Container sizes are 1lb. and 0.5lbs.
This voluntary recall is being initiated because the following Indian snack may contain undeclared cashews and colors (Yellow 5 & 6):  Kaju Katri
New Punjab Kaju Roll is an Indian snack cut into squares. Product is packaged in clear plastic container with a clear plastic lid. Container sizes are 1lb. and 0.5lbs.
This voluntary recall is being initiated because the following Indian snack may contain undeclared cashews and colors (Yellow 5 & 6):  Kaju Roll
New Punjab Kaju (Kajoo) Fry is the Indian translation for Toasted Fried Cashews. Product is packaged in clear plastic container with a clear plastic lid. Container sizes are 1lb. and 0.5lbs.
This voluntary recall is being initiated because the following Indian snack may contain undeclared cashew nuts:  Kaju Fry
New Punjab Ladoo is a ball-shaped Indian snack coated with almonds and/or pistachios. Product is packaged in clear plastic container with a clear plastic lid. Container sizes are 1lb. and 0.5lbs.
This voluntary recall is being initiated because the following Indian snack lacks an ingredient label.  Product may contain undeclared nuts (almonds, pistachios), undeclared colors (Yellow 5&6, Blue 1), and  wheat-uses the term farina:  Ladoo
New Punjab Chum Chum is a oval-shaped Indian snack coated with almonds and/or coconuts. Product is packaged in clear plastic container with a clear plastic lid. Container sizes are 1lb. and 0.5lbs.
This voluntary recall is being initiated because the following Indian snack may contain undeclared almonds, undeclared coconut, undeclared colors (Yellow 5&6, Blue 1),  and wheat-uses the term farina:  Chum Chum
New Punjab Rosgula is a ball-shaped Indian snack. Product is packaged in clear plastic container with a clear plastic lid. Container sizes are 1lb. and 0.5lbs.
This voluntary recall is being initiated because the following Indian snack may contain undeclared almonds, undeclared colors (Yellow 5&6, Blue1), and wheat-uses the term farina:  Rosgula
Adrucil (fluorouracil injection, USP) Pharmacy Bulk Package Not for Direct Infusion, 5 g/100 mL (50 mg/mL), For Intravenous Use Only, Rx Only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-3019-11
Presence of Particulate Matter: Black particulate matter was identified as aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals.
Distribution US nationwide to AL, AK, CA, DE, FL, GA, HI, ID, IL, IN, KS, KY, ME, MD, MA, MI, MS, MO, NM, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA; Canada and Dubai
Breast Pack - contains Devon Light Glove Used during surgery
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.
Basic Pack - contains Devon Light Glove Used during surgery
Advanced Vein Care - contains Devon Light Glove Used during surgery
Vein Pack, Vein Treatment II Pack, Vein Brunswick Pack, Vein No Lidocaine Pack, Vein Ablation Pack - contains Devon Light Glove Used during surgery
Endovenous Kit, Endo Pack and Endovenous Laser Kit - contains Devon Light Glove Used during surgery
Phleb Pack and Laser Phleb Pack - contains Devon Light Glove Used during surgery
Standard Pack - contains Devon Light Glove Used during surgery
Lipo Pack, Liposuction Expended Pack, and Liposuction Tray - contains Devon Light Glove Used during surgery
Lipo/Buttocks  Pack - contains Devon Light Glove Used during surgery
Vaginal Rejuvenation Pack - contains Devon Light Glove Used during surgery
General Pack - contains Devon Light Glove Used during surgery
Vein & Vascular Pack - contains Devon Light Glove Used during surgery
Laser Evlt Pack and Laser One Leg Evlt - contains Devon Light Glove Used during surgery
Breast Augmentation Pack and Breast Augmentation Expanded Pack - contains Devon Light Glove Used during surgery
Tummy Tuck Pack - contains Devon Light Glove Used during surgery
Surgical Pack and  General Surgery Pack - contains Devon Light Glove Used during surgery
Mississippi Pack - contains Devon Light Glove Used during surgery
Face Lift Pack - contains Devon Light Glove Used during surgery
Plastic Pack and Plastic HNP Pack - contains Devon Light Glove Used during surgery
Suction Pack - contains Devon Light Glove Used during surgery
ACL Pack - contains Devon Light Glove Used during surgery
Hand Pack - contains Devon Light Glove Used during surgery
Lima Pack - contains Devon Light Glove Used during surgery
Skin and Vein Pack - contains Devon Light Glove Used during surgery
Vasc Custom Kit - contains Devon Light Glove Used during surgery
Bariatric Pack - contains Devon Light Glove Used during surgery
Face Neck Pack - contains Devon Light Glove Used during surgery
Abdominal Pack and Abdom Pack - contains Devon Light Glove Used during surgery
Stradi 4500 - contains Devon Light Glove Used during surgery
Gyn Pack - contains Devon Light Glove Used during surgery
Head & Neck Pack - contains Devon Light Glove Used during surgery
Eye Pack - contains Devon Light Glove Used during surgery
Glaucoma Pack - contains Devon Light Glove Used during surgery
Shoulder Pack - contains Devon Light Glove Used during surgery
Knee Arthro Pack and Knee Arthro Pack II - contains Devon Light Glove Used during surgery
ENT Pack - contains Devon Light Glove Used during surgery
Podiatry Pack - contains Devon Light Glove Used during surgery
Minor Pack and Minor Pack II Pack - contains Devon Light Glove Used during surgery
Neurosurgery Pack - contains Devon Light Glove Used during surgery
Cysto Pack - contains Devon Light Glove Used during surgery
Open Pack - contains Devon Light Glove Used during surgery
Pediatric Pack - contains Devon Light Glove Used during surgery
Set Up Pack - contains Devon Light Glove Used during surgery
Blepharoplasty Pack - contains Devon Light Glove Used during surgery
Custom Pack - contains Devon Light Glove Used during surgery
DND Pack - contains Devon Light Glove Used during surgery
Orthopedic Split Drape Pack - contains Devon Light Glove Used during surgery
Arthroscopy Pack - contains Devon Light Glove Used during surgery
Upper Extremity Pack - contains Devon Light Glove Used during surgery
Integra LifeSciences Corp. d.b.a. Integra Pain Management
Integra Long Epidural Steroid Injection Needle (Tuohy Needle), 20 gauge x 5 inch. Plastic Hub, Metal Stylet, calibrations (10BX).  Integra Long Epidural Steroid Injection Needle (Catalogue #PITRW2050). Peel Pouch. The Integra Long Epidural Steroid Injection Needle is packaged in a labeled and sterilized sealed tyvek / plastic pouch.  The sterilized pouches are subsequently packaged in a case of 10 that is labeled, sealed and distributed to customers.  Pain management procedure trays contain Tuohy Epidural Injection Needles to administer steroid medication in the epidural space. The needles are also available as an individually packaged single use, sterile device, as was the case with the affected lot in question.
Integra LifeSciences Corp. d.b.a. Integra Pain Management Announces Voluntary Recall of Tuohy Needles (20 Gauge,  5 inch) due to incorrect packaging (labeled as 18 Gauge, 3. 5 inch).
Worldwide Distribution.  US nationwide, Canada, Australia, Belgium, Chile, Germany, Israel, Italy, Japan, Saudi Arabia, Singapore, South Africa, Turkey, and Uruguay.
Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube, Cuffless.  Model Numbers: 2.5NEF,3.0NEF,3.5NEF,4.0NEF,4.5NEF,2.5PEF,3.0PEF,3.5PEF,4.0PEF,4.5PEF,5.0PEF,5.5PEF,5.0PELF,5.5PELF,6.0PELF,6.5PELF,2.5NCF,3.0NCF,3.5NCF,4.0NCF,4.5NCF,2.5PCF,3.0PCF,3.5PCF,4.0PCF,4.5PCF,5.0PCF,5.5PCF,5.0PLCF,5.5PLCF,6.0PLCF,6.5PLCF,3.0NEF-P,3.5NEF-P,4.0NEF-P,4.5NEF-P,3.0PEF-P,3.5PEF-P,4.0PEF-P,4.5PEF-P,5.0PEF-P,5.5PEF-P,
All products manufactured since 2/2012.  Including All lot numbers beginning with 12, 13 and 14.
Medtronic is voluntarily recalling its Covidien Shiley'' Neonatal, Pediatric and Long Pediatric Tracheostomy Tube, Cuffless and Shiley'' Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGuard'' Cuff due to reports where patients who recently switched from the current Shiley Neonatal and Pediatric products to the affected products experienced discomfort and in some cases, breathing difficulties, corresponding to a negative effect on oxygen levels.
Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGuard Cuff.   Intended for use in providing tracheal access for airway managements.
Nationwide Distribution including AK AZ CA CT FL IA IL KY MA MD MT NC NE NH NY OH OR SC VA WA and WI.
Philips GoSafe Communicator 7000L Personal emergency response system.
3189 devices total, 38 are subject to recall
Home communicator Model 7000L may not sense the phone line under certain unusual landline phone conditions.
CT, DC, DE, MA, MD, NC, NH, NJ, NY, PA, RI, VA, VT and WV.
DASANI Purified Water, 24/20 fl. oz. (1.25 pt) 591 mL, pack, Desani, The Coca Cola Company, Atlanta, GA 30313.
UPC Code: 0 499770 4, Date Codes: MAR 2116 KMA, MAR 2116 KMB, MAR 2116 KMC, MAR 2116 KMD, MAR 2816 KM A, MAR 2816 KM B, MAR 2816 KM C, MAR 2816 KM D, MAR 2816 KM E, MAR 2816 KM F, APR 1116 KM A, APR 1116 KM B, APR 1116 KM D, APR 1116 KM E, APR 1816 KM A, APR 1816 KM B, APR 1816 KM C, APR 1816 KM D, APR 1816 KM E and APR 2516 KM B.
There is the potential that some of the bottles may contain linear pieces of plastic from the bottle production.
Worldwide Distribution - Nationwide Distribution including Puerto Rico., and the countries of : Austria, Australia, Belgium, Canada, Denmark, France, Finland, Germany, Japan, Italy, New Zealand, Netherlands, Czech Republic, Portugal, Republic Korea,  Norway, Spain, Switzerland, Slovakia, Saudi Arabia, Slovenia,  and United Kingdom,
Siemens Healthcare Diagnostics Dimension Vista Systems, used with the Dimension Vista Intelligent Lab System software version 3.6.1.  In vitro diagnostic analyzer.
there is the potential for two software issues to occur in Vista software versions 3.6.1    Issue #1 :Samples stop processing without notification for Dimension Vista instruments running software version 3.6.1.   Issue#2:The Dimension Vista 1500 causing a series of unflagged, unexpected low results and complaints of results flagged with assay errors.
NY, NJ, CT, MD, NC via retail stores and one FL site
Bedessee Brown Betty BRAND COCONUT MILK Powder Mix, NET WT: 1) 1.76 OZ (50 g) and 2) 10.6 OZ.  IMPORTED BY BEDESSEE IMPORTS LTD. Brooklyn, NY USA 11208.  PRODUCT OF VIETNAM.
344 cartons (316 cartons/1.76 oz & 28 cartons/10.6 oz) (76 cartons are quarantined)
Canadian Food Inspection Agency processed a recall involving Brown Betty brand Coconut Milk Powder Mix which contains sodium caseinate but lacks ''milk'' declaration.
Worldwide Distribution - Nationwide Distribution and to the countries of : Argentina, Austria, Australia, Belgium, Bulgaria, Bahrain, Bolivia, Brazil, Belarus, Canada, Switzerland, Chile, China, Colombia, Croatia, Hungary, Indonesia, Ireland, Iraq, Jordan, Japan, Czech Republic, Germany, Denmark, Ecuador, Egypt, Spain, Finland, France, Greenland, Greece, Hong Kong, United Arab Emirate, United Kingdom, Kenya, Kuwait, Sri Lanka, Luxembourg, Libya, Mongolia, Martinique, Mexico, Malaysia, Namibia, Nigeria, Netherlands, Norway, Oman, Panama, Peru, Philippines, Pakistan, Poland, Saint Pierre and Miquelon, Portugal, Reunion, Romania, Russia, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Senegal, Thailand, Tunisia, Turkey, Trinidad and Tobago, Taiwan, Uruguay, Venezuela, Serbia, Yemen, Mayotte and South Africa.
The PowerLED / X-TEN / VOLISTA Surgical Light Systems are surgical light systems intended to be used to provide visible illumination of the surgical area or the patient. Ceiling surgical light systems typically include one or more arms that are able to rotate 360 degrees around a central axis.
Maquet Suspension Arms used with PowerLED/X-TEN/Volista Surgical Light Systems may grind at the junction of the suspension arms which can cause paint chips or particles to fall into the surgical field, when the suspension arms are mounted above the surgical table.
Dill Pickle Lite Works Popcorn , lot number 15111, packaged in a 4 oz foil white bag with black and green lettering.
Lot code 15111, Best by date SEP 17, 2015
The product contains an allergen that is not declared on the label (Milk)
Bupivacaine Hydrochloride Inj., USP, 0.5% (5 mg/mL), Preservative-Free, 30 mL Single Use Vials, Rx only.  HOSPIRA, INC., LAKE FOREST, IL 60045 USA. NDC: 0409-1162-02.
Presence of Particulate Matter: Presence of free-floating and embedded iron oxide particles.
U.S. Nationwide, Kuwait, Bahrain and Israel.
Magnesium Sulfate Injection, USP, 50%, 20mL, Single dose Fliptop Vial, For IV or IM use, Rx only, Manufactured  by Hospira, Inc. 4285 Wesleyan Blvd Rocky Mount, NC 27804 for Hospira, Inc. 275 N Field Drive, Lake Forest, IL 60045. NDC 0409-2168-02
Failed pH Specifications:12 month stability testing
Texas; Arkansas; District of Columbia; Kansas; Oklahoma
Red Blood Cells Leukocytes Reduced Irradiated
Blood products, collected in a manner that lacked assurance of sterility, were distributed.
Worldwide Distribution - US Nationwide and the countries of Belgium, United Kingdom, Denmark, Netherlands, Sweden, Iceland, France, Saudi Arabia, Australia, Philippines and Thailand.
Volcano s5/s5x/CORE Mobile Intravascular Ultrasound Imaging and Pressure System;  Product/Part numbers: s5 - 804200-002 and 804200-014;  s5x - 807300-001;  CORE MOBILE - 400-0100.01.    Product Usage:  The Volcano s5/s5i Series Intravascular Imaging and Pressure System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. It is also indicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures. ChromaFlo is indicated for qualitative blood flow information from peripheral and coronary vasculature; flow information can be an adjunct to other methods of estimating blood flow and blood perfusion. VH IVUS intended to be used in conjunction with imaging catheters during diagnostic ultrasound imaging of the peripheral and coronary vasculature. The Volcano VH IVUS System is intended to semi-automatically visualize boundary features and perform spectral analysis of RF ultrasound signals of vascular features that the user may wish to examine more closely during routine diagnostic ultrasound imaging examinations.
s5  Part number 804200-002 and 804200-014; s5x Part number  807300-001;  CORE MOBILE Part Number 400-0100.01.  All software versions
227 total units affected by the issue - all models
Volcano Corporation and Philips Healthcare became aware of a limitation in interoperability between the Philips brand Xper Flex Cardia Physio monitoring System and Volcano's sS/Si, Core, and ComboMap  systems. This limitation may impact the calculation of Fraction Flow Reserve (FFR) within the Volcano  System when the system is connected to the Xper Flex Cardia system via its aortic pressure auxiliary output.
Volcano s5i/s5ix/s5iz/CORE Intravascular Ultrasound Imaging and Pressure System;  Product/Part numbers: s5i -806300-020 ;  s5ix/s5iz -  807400-001;  CORE -  400-0 I 00.02.    Product Usage:  The Volcano s5/s5i Series Intravascular Imaging and Pressure System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. It is also indicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures. ChromaFlo is indicated for qualitative blood flow information from peripheral and coronary vasculature; flow information can be an adjunct to other methods of estimating blood flow and blood perfusion. VH IVUS intended to be used in conjunction with imaging catheters during diagnostic ultrasound imaging of the peripheral and coronary vasculature. The Volcano VH IVUS System is intended to semi-automatically visualize boundary features and perform spectral analysis of RF ultrasound signals of vascular features that the user may wish to examine more closely during routine diagnostic ultrasound imaging examinations.
Product/Part numbers: s5i -806300-020 ; s5ix/s5iz -  807400-001;  CORE -  400-0 I 00.02.      All software versions
ComboMap Intravascular Flow and  Pressure System; Product/Part number: Combo Map - 802745-001.    Product  Usage:  The Volcano s5/s5i Series Intravascular Imaging and Pressure System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. It is also indicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures. ChromaFlo is indicated for qualitative blood flow information from peripheral and coronary vasculature; flow information can be an adjunct to other methods of estimating blood flow and blood perfusion. VH IVUS intended to be used in conjunction with imaging catheters during diagnostic ultrasound imaging of the peripheral and coronary vasculature. The Volcano VH IVUS System is intended to semi-automatically visualize boundary features and perform spectral analysis of RF ultrasound signals of vascular features that the user may wish to examine more closely during routine diagnostic ultrasound imaging examinations. The ComboMap is intended to be used in peripheral and coronary arteries to measure intravascular blood pressure and/or blood flow velocities during diagnostic angiography and/or interventional procedures.
Product/Part numbers: Combo Map - 802745-001.   All software versions
Losartan potassium tablets USP, 25 mg, 90- count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1T9 by Apotex Research Private Limited, Plot 1 & 2, Bommasandra Industrial Area, 4th Phase Jigani Link Road, Bangalore, Karnataka, 560099, India  NDC 60505-3160-9
Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.
Losartan potassium tablets USP, 100 mg, 90-count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1T9 by Apotex Research Private Limited, Plot 1 & 2, Bommasandra Industrial Area, 4th Phase Jigani Link Road, Bangalore, Karnataka, 560099, India  NDC 60505-3162-9
Losartan potassium tablets USP, 50 mg, 90-count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1T9 by Apotex Research Private Limited, Plot 1 & 2, Bommasandra Industrial Area, 4th Phase Jigani Link Road, Bangalore, Karnataka, 560099, India  NDC 60505-3161-9
Enalapril maleate and hydrochlorothiazide tablets USP, 10/25 mg, 100-count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1T9 by Apotex Research Private Limited, Plot 1 & 2, Bommasandra Industrial Area, 4th Phase Jigani Link Road, Bangalore, Karnataka, 560099, India, NDC 60505-0209-1
PowerPICC SOLO Catheter with Sherlock 3CG TPS Stylet 4F Maximal Barrier Tray with Microintroducer The PowerPICC Solo'' catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.
Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates on the primary labeling.
PowerPICC SOLO Catheter with Sherlock 3CG (TPS) Stylet 5F Maximal Barrier Tray with Microintroducer The PowerPICC Solo'' catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.
PowerPICC SOLO Catheter with Tip Location System (TLS) Stylet 4F Nurse Full Tray with Microintroducer (with Lidocain) The PowerPICC Solo'' catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.
PowerPICC SOLO2 Catheter 4F Maximal Barrier Tray with Microintroducer (Single-Lumen) (Sherlock) The PowerPICC Solo'' catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.
Natrelle Re-sterilizable Breast Implant Sizer, Size: 410 cc, Style No. MSZFX410.   The product is packaged in a thermoformed tray (double sterile barrier) and enclosed in a labeled carton.
Allergan is recalling the NATRELLE 410cc Re-Sterilizable Breast Implant Sizer because the expired product was shipped to the user level.
Kraft Non-Dairy Creamer, Net WT/Contenido Neto 16 oz (454 g) SKU 2100042503.   Kraft Non-Dairy Creamer, Net WT/Contenido Neto 6 oz (170g) SKU 2100042202.      Country Barn, Coffee Creamer, Non-Dairy creamer, Net WT/Peso Neto 6 oz ( 170g), SKU 3540603606.    Country Barn, Coffee Creamer, Non-Dairy creamer, Net WT/Peso Neto 11 oz ( 312g), SKU 3540603611.    Libby's Coffee Creamer, Non-Dairy creamer, 16 oz (544 g) SKU 1614308012.    Libby's Coffee Creamer, Non-Dairy creamer, 22 oz  SKU 1614308013.      Libby's Coffee Creamer, Non-Dairy creamer, 35.3 oz  SKU 1614308014.      Golden Flag, Non Dairy Creamer, Net WT 22 oz (1 lb 6 oz) 624 g, SKU 6464410734.
Kerry, Inc. is voluntarily recalling all Nondairy Creamer produced between May 12, 2015 and May 28, 2015 due to the potential for a few packages to contain small pieces of metal from a broken screen on the production line.
Kraft French Vanilla, Creamer, Non-Dairy Creamer, Net WT/Contenido Neto 35.3 oz (1 kg) SKU 2100002971.   Publix, Nondairy, FrenchVanilla, Naturally and Artificially Flavored Coffee Creamer, Net Wt 15 oz (425 g), SKU 4141501625.
US Distribution to states of: MO and SC.
TITANIUM END CAP WITH T40 STARDRIVE RECESS, 0MM EXTENSION FOR TITANIUM TIBIAL NAILS-EX; Synthes Tibial Nail System EX is intended to stabilize fractures of the proximal and distal tibia and the tibial shaft; open and closed tibial shaft fractures; certain pre-and post-isthmic fractures; and tibial malunions and non-unions.
A specific part and lot number were packaged and shipped prior to the completion of a required internal inspection. The nonconformance is not expected to pose an additional health risk to the patient or user if the device was used.  No adverse events reported.
Worldwide Distribution - Nationwide Distribution and to the countries of : Austria, Belgium, Canada, France, Germany, Greece, Hong Kong, Italy, India, Japan, South Korea, Mexico, P.R. China, Poland, Republic of South Africa, Romania, Saudi Arabia, Singapore, Spain, Switzerland, Thailand, and United Kingdom.
Primus (THE BTE WS30), model PrimusRS (PRRS) and Primus+ (PR30) a measuring exercise equipment device designed to provide active and passive torque resistance to patient motion during rehabilitation therapy.
Primus (THE BTE WS30), model PrimusRS (PRRS) and Primus+ (PR30)
The Primus that includes the optional Chop / Lift Bar. There is a remote possibility that the Chop / Lift Bar could get accidently detached from the snap hook in specific use scenarios when the bar is rotated and twisted around the snap hook.    The snap hook could open, resulting in possible injury to the user due to a fall.  BTE is voluntarily processing a field correction to eliminate this risk.
Worldwide Distribution - US: Nationwide and the countries of: Australia, India, Japan, Korea, New Zealand, Singapore, Thailand, Vietnam, Canada, Bulgaria, Czech Republic, Estonia, Hungary, Israel, Latvia, Lithuania, Poland, Romania, Slovakia, Switzerland, Turkey, China Hong Kong, Taiwan, Brazil, Colombia, Costa Rica, Guatemala, Mexico, Egypt, Morocco, South Africa, Austria, Belgium, Denmark, Finland, France, Germany, Greece, Italy, Netherlands Norway, Portugal, Spain, Sweden, UK and Ireland.
Block Versions Used by Dental Offices often referred to as chairside milling: Lava Ultimate Restorative for CEREC, Compatible with Sirona mill 2912x, 2914x, 3312x, 3314x.   Lava Ultimate Restorative for E4D Compatible with E4D mills, same mandrel format as Planmill 3112x, 3114x, 4012x, 4014x.   Lava Ultimate for Straumann milling centers 1334x.   Lava Ultimate CAD/CAM Restorative for TS150, Compatible with TS150 (IOS Technologies), Glidewell Laboratories, 2614x.   Lava Ultimate Restorative with Blue Mandrel, Pedestal Mandrel, compatible with Carestream CS 3000, Roland DWX-50, Roland DWX-4, 1314x, 2012x, 2110x.    Lava Ultimate Restorative for Planmill, Compatible with Planmill mills, same mandrel format as E4D, 4212x, 4214x, 4312x, 4414x, 5072x, 5074x.   Lava Ultimate Restorative for Ceramill, Compatible with Ceramill mills manufactured by Amann Girrbach, 4514x, 4714x, 5044x.    Frame/Blank Version Used by Dental Laboratories: Lava Ultimate Implant Crown Restorative, Compatible with Lava Milling Equipment (Lava blocks bonded into frames. These are also known as blanks.), 69140-69149, 69150-69159, 69160-69163.
All products in the Lava Ultimate product family.
3M is initiating  a Field Correction to remove the crown indication from all Lava Ultimate products. These products will continue to be indicated for onlays, inlays and veneers.
US Nationwide Distribution in the states LA, TX, and PR.
Nakoma-SL Anterior Cervical Plating System's Variable Single Barrel Drill Guide   Product Usage:  The Nakoma-SL ACP System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The Nakoma ACP System is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusion in patients with the following indications: Degenerative Disk Disease, Trauma, Tumors, Deformities or curvatures, Psuedoarthrosis, Failed previous fusions, Spondylolistesis, and Spinal Stenosis.
Inadequate interference between the screw and the plate when screw implanted into the plate at angulation greater than 7 degrees can result in the screw advancing through the plate during implantation.
Garden Fresh Steakhouse Potato Salad Kit, CODE#1076, NET WT 10.75 LBS (4.876 KG) , UPC 0 01 11596 51076 4.
Garden Fresh Foods, Inc. reported one case of Steakhouse Potato Salad Kit tested presumptive for Listeria monocytogenes.
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Songer Spinal Cable System, Single Cable, Crimp, Bar, Stainless Steel, Sterile.   The DePuy Spine Cable System can be utilized anywhere monofilament wire has been previously found to be indicated.
Lot Number: PL 193368 Manufacture Date: 09/09/2014  Expiration Date: 09/09/2019
RTI Surgical Inc. (RTI) Doing business as Pioneeer Surgical Technology is conducting a voluntary recall on one lot of implantable Songer Spinal Cable System, Single Cable, Crimp, Bar, Stainless Steel, Sterile which is distributed by DePuy Spine Inc.  It has been identified that the box end label is incorrectly labeled as ''Titanium'' instead of ''Stainless Steel''.
Distributed in the states of TX, MD, PA, NJ, NC, MA, AZ, GA, FL, and AR. and the countries of Costa Rica CP and The Netherlands.
A.L.P.S. Foot Locking Calcaneus Plate,Small-Right.   Provides the orthopaedic surgeon a means of bone fixation and helps generally in the management of fractures and reconstructive surgeries.
Part Number: 816209001; Lots: 015840, 124980, 948210 and P0059, P0076, or P0061 will be etched on the plate itself.
Biomet initiated this action following an investigation which identified that the thread location, on one of the thread holes, is offset from the axis of the predill hole; therefore, the threads are too deep on one side and too shallow on the other.  This issue may present the following risks:  If the locking screw does not achieve proper purchase, the screw may back out of the plate.  This may require a revision surgery to replace or remove the screw and/or plate.  Due to the threads not being uniformly loaded, as designed; they may shear off, causing metal slivers.  This may cause soft tissue irritation.
Champ's Sliced Crimini Mushrooms, net weight 227 gram (8 oz), UPC 6 78286 88877 5.   The product's label is read in parts: ''***Champ's Mushrooms***Sliced Crimini Mushrooms***KEEP REFRIGERATED***Product of Canada***Aldergrove. B.C V4W 2Z6***''.
Champ's Sliced Crimini Mushrooms, product of Canada, are recalled due to the potential to be contaminated with Listeria monocytogenes
Redwood Hill Farm Raw Milk Feta; Artisan Goat Cheese; Perishable, keep refrigerated.  Ingredients: Raw goat milk, sea salt, Vegetarian enzyme, cultures.  Packaged in a 3 lb. plastic bucket (in brine), Two buckets per case.    Handmade in Sebastopol, CA  Redwood Hill Farm & Creamery,  Sebastopol, CA
97 cases of 2 x 3 lb. buckets (582 pounds)
One lot of Raw Milk Goat Cheese tested positive for Listeria monocytogenes.
Amlodipine besylate tablets, USP 2.5mg, packaged in 10-count blisters (NDC 68084-498-11); 10 blister packs per carton (NDC 68084-498-01); Rx only,  Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.
CGMP Deviations: Firm did not adequately investigate customer complaints.
Amlodipine besylate tablets, USP 5mg, packaged in 10-count blisters (NDC 68084-505-11); 10 blister packs per carton (NDC 68084-505-01); Rx only,  Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.
Amlodipine besylate tablets, USP 10 mg, packaged in 10-count blisters (NDC 68084-506-11); 10 blister packs per carton (NDC 68084-506-01); Rx only,  Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.
Azithromycin tablets, USP 500mg, packaged in 10-count blisters (NDC 68084-279-11); 3 blister packs per carton (NDC 68084-279-21); Rx only,  Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.
Azithromycin tablets, USP 600mg, packaged in 10-count blisters (NDC 68084-464-11); 3 blister packs per carton (NDC 68084-464-21); Rx only,  Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.
Azithromycin tablets, USP 250mg, packaged in 10-count blisters (NDC 68084-278-11); 10 blister packs per carton (NDC 68084-278-01); Rx only,  Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.
Clarithromycin tablets, USP 500mg, packaged in 10-count blisters (NDC 68084-437-11); 5 blister packs per carton (NDC 68084-279-65); Rx only,  Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.
Famotidine tablets, USP 20mg, packaged in 10-count blisters (NDC 68084-172-11); 10 blister packs per carton (NDC 68084-172-01); Rx only,  Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.
Lisinopril tablets, USP 5mg packaged in 10-count blisters (NDC 68084-060-11); 10 blister packs per carton (NDC 68084-060-01); Rx only,  Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.
Lisinopril tablets, USP 10mg packaged in 10-count blisters (NDC 68084-061-11); 10 blister packs per carton (NDC 68084-061-01); Rx only,  Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.
Lisinopril tablets, USP 20mg packaged in 10-count blisters (NDC 68084-062-11); 10 blister packs per carton (NDC 68084-062-01); Rx only,  Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.
Lisinopril tablets, USP 40mg packaged in 10-count blisters (NDC 68084-064-11); 10 blister packs per carton (NDC 68084-064-01); Rx only,  Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.
Zonisamide capsules, USP 100mg packaged in 10-count blisters (NDC 68084-008-11); 5 blister packs per carton (NDC 68084-008-65); Rx only,  Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.
Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed.
Capecitabine Tablets, USP, 500 mg, 120-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-2512-78, UPC 3 0378-2512-78 6.
Failed Dissolution Specifications: low out-of-specification (OOS) results for dissolution were obtained at the nine-month stability point.
Maximum Strength Analgesic Thera-Gesic Pain Relieving Creme Relief from: Joint and Muscle Soreness, Arthritis, Back Aches; 1/8 Oz Sachet, OTC, Manufactured for Mission Pharmacal Company 10999 IH 10 West, Suite 1000 San Antonio, TX 78230 by Mission Pharmacal Company 38505 IH 10 West Boerne, TX 78006. NDC 0178-0320-12
Subpotent Drug: menthol and methyl salicylate below specification
CORTISOL-MC, 10mg CAP, packaged in 30 and 90 count bottles, Rx Only, ABRAMS ROYAL pharmacy II, 4909 W Park Blvd, Suite 177, Plano, TX 75093 --- NDC 88888-0043-31
Failed Content Uniformity Specifications: Failed Uniformity of Dosage Units specifications.