Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
NY, PA, FL, GA, IN, KY, MA, MD, TN, VA, IN, OH, MI
GOLDEN SMELL brand Hot Pot Meat Ball Medly, NET WT:1 LB (454g), UPC 8 881028 964381, Product of China -- Distributor: Strong America Ltd., 2-39 4th Ave., Long Island City, NY 11101 --- Nutrition Facts information: Serving Size: 1 oz (28g), Servings Per Container: 16
UPC  8 881028 964381 and no other coding
The product was found to contain undeclared eggs based on sampling and analysis by New York State Department of Agriculture & Markets.
Distributed in the states of MN, KY, MA, VA, TX, NC, HI, FL, AZ, CT, and WY and the countries of Argentina, Australia, Austria, Canada, Denmark, Germany, Netherlands, Russia, Saudi Arabia, Singapore, Spain, and Switzerland.
Patient Support Material Number: 9890 010 87431 used with: BuckyDiagnost ; Model: 704060/706037
All patient support for stitching are affected.
1517 systems, not all units have the patient support accessory
The hook does not securely hold the footplate in vertical position. Therefore the footplate can fall or swing down and may hurt the operator or patient.
Patient Support Material Number: 9890 010 87431, used with:EasyDiagnost ; Model: 706050
260 units, not all units have the patient support accessory
AL ;  AR ;   AZ ;   CA ;   CO ;   CT ;   DE ;   FL ;   GA ;   IA ;   IL ;   IN ;   KS ;   KY ;   LA ;   ME ;   MI ;   MN ;   MO ;   MS ;   NC ;   NE ;   NH ;   NJ ;   NV ;   NY ;   OH ;   OR ;   PA ;   SC ;   TN ;   TX ;   UT ;   VA ;   WA ;   WI ;
Rachael Ray Nutrish Natural Food For Cats Paw Lickin Chicken and Liver  Net Wt. 2.8 oz.;     on side of cup: Best Before (up to and including) Aug 17 2015;     On bottom of cup: Distributed By: Ainsworth Pet Nutrition, Meadville, PA 16335  Product of Thailand.    In plastic cup with foil seal
Best Buy dates up to and including: Aug 17 2015
Rachael Ray Nutrish Natural Food For Cats Ocean Fish & Chicken Catch-Iatore  Net Wt. 2.8 oz.;     on side of cup: Best Before (up to and including) DEC 1 2016;     On bottom of cup: Distributed by: Ainsworth Pet Nutrition, Inc., Meadville, PA 16335;    In plastic cup with foil seal
Best Buy dates up to and including: Dec 1 2016
Rachael Ray Nutrish Natural Food For Cats; Ocean Fish-A-Licious;  Net Wt. 2.8 oz.;     on side of cup: Best Before (up to and including) DEC 1 2016;     On bottom of cup: Distributed by: Ainsworth Pet Nutrition, Inc., Meadville, PA 16335;    In plastic cup with foil seal
Rachael Ray Nutrish Natural Food For Cats 12 Count  12 - 2.8 oz. cups  Net Wt. 33.6 oz.  Best Before (up to and including) DEC 1 2016  Distributed By: Ainsworth Pet Nutrition Inc., Meadville, PA 16335      Variety:  Chicken Lovers Variety Pack;   Ocean Lovers Variety Pack
Ocean lover's - 18006 cs 12 units/cs; Chicken Lovers - 33,117 cs 12 units/cs
Rachael Ray Nutrish Natural Food For Cats; Lip Smackin' Sardine & Mackerel;  Net Wt. 2.8 oz. cups;     on side of cup: Best Before (up to and including) DEC 1 2016;     On bottom of cup: Distributed by: Ainsworth Pet Nutrition, Inc., Meadville, PA 16335;    In plastic cup with foil seal
Rachael Ray Nutrish Natural Food For Cats; Tuna Purrfection;  Net Wt. 2.8 oz. cups;    on side of cup: Best Before (up to and including) DEC 1 2016;     On bottom of cup: Distributed by: Ainsworth Pet Nutrition, Inc., Meadville, PA 16335;    In plastic cup with foil seal
Worldwide Distribution - US Nationwide and the countries of: Canada,Australia, Austria, Brazil, Chile, China, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, South Africa, Spain, Switzerland and United Kingdom.
Philips Healthcare Allura Xper Series: Allura Xper FD10  Allura Xper FD10/10  Allura Xper FD20  Allura Xper FD21  Allura Xper FD22  Allura Xper FD23  Allura Xper FD24  Allura Xper FD25    Product  Usage:  The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, interventional procedures (such as PTCA, stent placement, embolization and thrombolysis and atherectomics), pacemaker Implantations and electrophysiology (EP). Use of the Allura Xper series system in the OR environment is restricted; the system should only be used for endo-vascular procedures. The Philips Integris Allura 9F is intended for diagnostic cardiovascular, vascular and interventional procedures
System :     S/N :                Model: 722003 30 Allura Xper FD10  722010 670 Allura Xper FD10  722011 167 Allura Xper FD10/10  722012 1951 Allura Xper FD20  722012 536 Allura Xper FD21  722012 504 Allura Xper FD22  722012 748 Allura Xper FD23  722012 536 Allura Xper FD24  722012 579 Allura Xper FD25
Monitor Ceiling Suspension system may fall
Philips Healthcare Allure BiPlane Series: Model              722013 Allura Xper FD20 BIPLANE R7.6  722013 Allura Xper FD20 BIPLANE R7.7  722013 Allura Xper FD20 BIPLANE R7.8  722013 Allura Xper FD20 BIPLANE R7.9  722013 Allura Xper FD20 BIPLANE R7.10    Product Usage:  The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, interventional procedures (such as PTCA, stent placement, embolization and thrombolysis and atherectomics), pacemaker Implantations and electrophysiology (EP). Use of the Allura Xper series system in the OR environment is restricted; the system should only be used for endo-vascular procedures. The Philips Integris Allura 9F is intended for diagnostic cardiovascular, vascular and interventional procedures
System :     S/N :                Model: 722013 262 Allura Xper FD20 BIPLANE R7.6  722013 422 Allura Xper FD20 BIPLANE R7.7  722013 195 Allura Xper FD20 BIPLANE R7.8  722013 173 Allura Xper FD20 BIPLANE R7.9  722013 225 Allura Xper FD20 BIPLANE R7.10
Philips Healthcare  INTEGRIS cardio system Model :  722121    Product Usage:  The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, interventional procedures (such as PTCA, stent placement, embolization and thrombolysis and atherectomics), pacemaker Implantations and electrophysiology (EP). Use of the Allura Xper series system in the OR environment is restricted; the system should only be used for endo-vascular procedures. The Philips Integris Allura 9F is intended for diagnostic cardiovascular, vascular and interventional procedures
Philips Healthcare  INTEGRIS vascular System Model :  722122    Product Usage:  The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, interventional procedures (such as PTCA, stent placement, embolization and thrombolysis and atherectomics), pacemaker Implantations and electrophysiology (EP). Use of the Allura Xper series system in the OR environment is restricted; the system should only be used for endo-vascular procedures. The Philips Integris Allura 9F is intended for diagnostic cardiovascular, vascular and interventional procedures
Philips Healthcare  INTEGRIS H5000F/Allura 9F Model :  722017    Product Usage:  The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, interventional procedures (such as PTCA, stent placement, embolization and thrombolysis and atherectomics), pacemaker Implantations and electrophysiology (EP). Use of the Allura Xper series system in the OR environment is restricted; the system should only be used for endo-vascular procedures. The Philips Integris Allura 9F is intended for diagnostic cardiovascular, vascular and interventional procedures
Philips Healthcare  Xper cardio systems Model :  722123    Product Usage:  The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, interventional procedures (such as PTCA, stent placement, embolization and thrombolysis and atherectomics), pacemaker Implantations and electrophysiology (EP). Use of the Allura Xper series system in the OR environment is restricted; the system should only be used for endo-vascular procedures. The Philips Integris Allura 9F is intended for diagnostic cardiovascular, vascular and interventional procedures
Philips Healthcare   Xper vascular system Model :  722124    Product Usage:  The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, interventional procedures (such as PTCA, stent placement, embolization and thrombolysis and atherectomics), pacemaker Implantations and electrophysiology (EP). Use of the Allura Xper series system in the OR environment is restricted; the system should only be used for endo-vascular procedures. The Philips Integris Allura 9F is intended for diagnostic cardiovascular, vascular and interventional procedures
Philips Healthcare  Xper cardio systems R7.6 Model : 722133    Product Usage:  The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, interventional procedures (such as PTCA, stent placement, embolization and thrombolysis and atherectomics), pacemaker Implantations and electrophysiology (EP). Use of the Allura Xper series system in the OR environment is restricted; the system should only be used for endo-vascular procedures. The Philips Integris Allura 9F is intended for diagnostic cardiovascular, vascular and interventional procedures
Philips Healthcare  Xper vascular systems R7.6 Model : 722134    Product Usage:  The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, interventional procedures (such as PTCA, stent placement, embolization and thrombolysis and atherectomics), pacemaker Implantations and electrophysiology (EP). Use of the Allura Xper series system in the OR environment is restricted; the system should only be used for endo-vascular procedures. The Philips Integris Allura 9F is intended for diagnostic cardiovascular, vascular and interventional procedures
2-DEOXY-D-GLUCOSE Powder, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY
Penicillin Cross Contamination: potentially contaminated with penicillin
E3 CREAM, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY
HYDROXOCOBALAMIN Injection, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY
ESTRIOL Capsules, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY
ESTRIOL Vaginal Creams, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY
ESTRIOL Suppositories, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY
ESTRIOL Vaginal Gels, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY
ESTRIOL Face Creams, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY
ESTRIOL Creams, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY
ESTRIOL Gels, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY
BI-EST Capsules, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY
BI-EST Gels, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY
BI-EST Lozenges, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY
BI-EST Suspensions, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY
BI-EST Creams, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY
TRI-EST Capsules, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY
TRI-EST Lozenges, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY
TRI-EST Liquids, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY
TRI-EST Gels, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY
METHYLFOLATE Capsules, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY
METHYLFOLATE Injection, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY
HUMAN CHORIONIC GONADOTROPIC (HCG) Injection, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY
HUMAN CHORIONIC GONADOTROPIC (HCG) Sublingual Drops, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY
No foreign distribution.  Products were sold nationwide.
Josie Maran  Argan Oil Face Cream  1.7 oz. jar and 2mL sample packet
Josie Maran Cosmetics, LLC is recalling Josie Maran Argan Oil Face Cream due to specifications and standards for preservative issues and potential Enterobacter gergoviae contamination.
The product was sent to one distributor. The distribution center is Whole Foods Midwest Distribution center, Munster Indiana.
The product is in the form of a salad kit. It contains two plastic bags and one plastic container. The contents are; salad 3.7 lbs/bag, arugula 2.5 oz/bag, and a 1.2 lb cup of dressing. More details of the packaging are currently pending.
Consumers found a piece of wire in Green Quinoa Cous Cous Salad.
DR. VENESSA'S FORMULAS ULTIMATE ANTIOXIDANT TABLETS DIETARY SUPPLEMENT, 120 count bottles, UPC 606851551205
Lot Number 132415 (expiration date 05/16) and Lot Number 141381 (expiration date 06/17)
The dietary supplement contains undeclared milk and crustacean shellfish based on FDA's inspection.
Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator, Starter Kit (Racepinephrine 11.25 mg) 10 individual foil wrapped vials with 1 EZ Breathe Atomizer per carton, Manufactured By: nephron pharmaceuticals corporation, Orlando, FL --- NDC 0487-2784-10
Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator  Refills (Racepinephrine USP 11.25 mg), 30 individual foil wrapped vials per carton, Manufactured By: nephron pharmaceuticals corporation, Orlando, FL --- NDC 0487-2784-01
Product was shipped to a distribution center in KS and then to restaurants in IA, KS, MO, MN, NE, OK, and SD.  No foreign, government, or military distribution.
Founders Pride Chocolate Chip Cookies 120 - 2.5 oz  frozen dough pieces packaged per case, Net Wt. 18.75 lbs. (8.50 Kg.)  The responsible name on the label is Custom Foods, Inc., DeSoto, KS 66018.
Product may be contaminated with peanuts.
Product was distributed to IA, KS, MO, NE, SD, and OK.  No foreign, govermnet, or military distribution.
Goodcents deli fresh subs Fresh Baked Giant Cookie, Chocolate Chip Cookie, Serving Size:  1 Cookie, Approx. NET WT. 2.5 oz.  Frozen cookie dough is manufactured by Custom Foods Inc. De Soto, KS 66018.
There are no identifiable codes on the product - baked daily between 8/31-9/22/2015.
Cumin Ground  Product of India  50 lbs  C/7784
Blood product, collected from a donor who traveled to a malarial endemic area, was distributed.
Product was distributed to distribution centers in the following states:  FL, GA, IN, KY, MD, MI, NC, NY, and OH.  There was no foreign, military, or government distribution.
Wylwood Mixed Vegetables Steam Bag Keep Frozen Net Wt / Peso 12 oz  (340 g) , UPC 0 51933 02030 6.  Product is packed in cases of 18-12 oz. bags.  Distributed by/for:  Save-A-Lot Food Stores Ltd., Earth City, MO 63045.
Sample of the recalled lot was positive for Listeria monocytogenes.
Whole Kernel Corn Frozen Fresh Net Wt / Peso Neto 16 oz  (454 g) 1 lb, UPC 0 51933 20293.  Product is packed in cases of 18-16oz. bags.  Distributed by/for:  Save-A-Lot Food Stores Ltd., Earth City, MO 63045.
Blood Centers of the Pacific - Irwin Center
Platelet Pheresis product, in which the platelet product yield was below  the 3.0 x 10^11 requirement, was distributed.
Blood product, possibly contaminated with air, was distributed.
Distributed in the states of VA, AL, FL, and CA.
HYDRO-TEMP(R) Neonatal Temperature Skin Sensor, REF HNICU-32, 50 units per box, NON STERILE, Rx only.
DeRoyal manufactured four lots of HNICU-32, Hydro-Temp(R) Neonatal Temperature Skin Sensor incorrectly. The pins contained in the probe were soldered incorrectly. When probe is connected to the proper port, this defect results in the inability to read or display temperatures on the infant warming system.
Stryker Medical Division of Stryker Corporation
Worldwide Distribution-US (nationwide) including DC and Guam, and  the countries of New Zealand Canada Chile Hong Kong Colombia Argentina Brazil France Germany Italy Netherlands Spain Switzerland United Kingdom India Japan South Korea Mexico South Africa Poland Singapore.
Two-stage and three-stage I.V. poles are shipped as an optional accessory to a bed or stretcher.  The I.V. poles are stationary, height adjustable stands intended to hold infusion liquids, infusion accessories, and/or other medical devices. They may be used on the following parent devices: Model 2030 (EPIC II), model 3005 S3 beds and stretcher. models 1105, 1105E, 1105X, 1105XE, 1115, 1115E, 1115X, 1115XE, 1125E, 1125X  and 1125XE.
Stryker 2-Stage and 3-Stage I.V. Poles distributed on beds, stretchers, and in service kits. This product field action is limited to I.V. Poles distributed between  01/07/2014 - 06/24/2014.    The following I.V. Pole option numbers come affixed to beds and stretchers:    Manufacturer Model Number and Product Description  2035-112-010; Head End Left, 2 Stage I.V. Pole  2035-113-011; Head End Right, 2 Stage I.V. Pole  0785-035-101; 26'', 2 Stage IV Pole Assembly  0785-035-200; 26'', 3 Stage IV Pole Assembly  0785-035-300; 30'', 3 Stage IV Pole Assembly  0785-035-401; 30'', 2 Stage IV Pole Assembly      The following I.V. Pole option numbers ship as service kits.    Manufacturer Service Kit Number and Product Description  1105-035-368; 30'' IV POLE 2 STAGE HE PR  1105-035-367; 30'' IV POLE 2 STAGE HE PL  1105-035-343; 30'' IV POLE 2 STAGE FE PR  1105-035-341; 30'' IV POLE, 2 STAGE HE, PR  1105-035-340; 30'' IV POLE, 2 STAGE FE, PL  1105-035-338; 30'' IV POLE, 2 STAGE FE, PL  1040-035-338; 2-STAGE IV POLEHEAD LT30'' ZM  0785-035-340; 2-STAGE IV POLE,HEAD LT, 30''  0785-035-341; 2-STAGE IV POLEHEAD RT 30''  0785-035-343; 2-STAGE IV POLE,FOOT RT, 30''  1105-035-344; 30'' IV POLE, 3 STAGE FE, PL  1105-035-342; 30'' IV POLE, 3 STAGE HE, PL  1105-035-339; 30'' IV POLE, 3 STAGE FE, PR  1105-035-369; 30'' IV POLE, 3 STAGE HE, PL  1105-035-366; 30'' IV POLE, 3 STAGE HE, PR  0785-035-339; 3-STAGE IV POLE,FOOT RT, 30''  0785-035-342; 3-STAGE IV POLE,HEAD LT, 30''  1105-035-644; 26'' IV POLE, 3 STAGE FL  1105-035-642; 26'' IV POLE, 3 STAGE HL  1105-035-639; 26'' IV POLE 3 STAGE FR  1105-035-637; 26'' IV POLE, 3 STAGE HR  0785-035-637; 3-STAGE IV POLE,HEAD RT, 26''  0785-035-639; 3-STAGE IV POLE,FOOT RT, 26''  0785-035-642; 3-STAGE IV POLE,HEAD LT, 26''  1105-035-643; 26'' IV POLE, 2 STAGE FR  1105-035-641; 26'' IV POLE, 2 STAGE HR  1105-035-640; 26'' IV POLE, 2 STAGE FL  1105-035-638; 26'' IV POLE, 2 STAGE HL  0785-035-638; 2-STAGE IV POLE,HEAD LT, 26''  0785-035-640; 2-STAGE IV POLE,FOOT LT, 26''  0785-035-641; 2-STAGE IV P
It was identified by a customer complaint that some I.V. poles were retracting/lowering from an extended position to the low height unexpectedly. An  investigation was initiated which identified that the I.V. Latch Housing was  nonconforming.  potential hazards:  '' Suspended I.V. pole retracts unexpectedly  '' Suspended I.V. pole retracts unexpectedly with pump/bags attached
Blood product, collected from a donor who received a piercing within one year of donation, was distributed.
Distributed US (nationwide) and the countries of Australia, Canada, Germany, Hong Kong, Italy, Japan, Malaysia, New Zealand, Netherlands, Poland, Romania, Spain, Sweden and Switzerland.
Stryker Orthopaedics Duracon Flat Tibial Wedge Cemented use only Sterile. Tibial Wedge is a component of Total Stabilizer Knee which consists of femoral component, tibial insert, modular offset adaptor, femoral/tibial stem extenders and tibial wedges. Tibial wedges are intended to be used with the Universal tibial baseplate to augment bone loss on the surface of the tibia.
Stryker Orthopaedics has received two customer complaints regarding Duracon Tibial Wedge implants puncturing the packaging's Tyvek lid(s).
American National Red Cross (The) - North Central Region
Blood and Blood Products for Reprocessing
Blood product, in which donor suitability was inadequately determined, was distributed.
Apheresis products, in which platelet yield did not meet specifications, were distributed.
Carbo-O-Philic 40 Cream 40% (Urea) tubes, a) 3 oz (85 g) (NDC 54162-640-03) , b) 7 oz (200 g) (NDC 54162-640-07), Rx Only For topical use only, Distributed by Geritrex Corporation, East Mount Vernon, NY 10550
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Carbo-O-Philic 40 Gel 40% (Urea) NET WT tube, .5 oz (15 g), Rx Only For topical use only, Distributed byGeritrex Corporation 144, Mount Vernon, NY 10550, NDC 54162-016-15
GRx HiCort 25 (hydrocortisone acetate 25 mg) Suppositories, 12-count box, Rx only, Distributed by Geritrex Corporation  Mount Vernon, NY 10550, NDC 54162-015-12
Polyethylene Glycol 3350-GRX Powder 100% jars a)  8.4 oz (250 g) (NDC 54162-335-02), b) Net wt. 16.9 oz  (500 g) (NDC 54162-335-05), Distributed by: Geritrex Corporation, Mount Vernon, NY 10550
Nationwide in US: Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas, and Utah
Prostin Injection 10 mcg/mL, 25 mcg/mL, 50 mcg/mL, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Ace-Promazine 10 mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
AMP50/B121MG Complex Mix/ML Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
B-12 1000/B6 1000 mcg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Bladder Mixture Prep, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Boric Acid 1% Ear Drop, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Butor/Nal/Hydro Nasal Susp, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Cyclosporine 1% Opth Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Dep-Estradiol 10 mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Depo-Testadiol 10/5mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Folic Acid Injection 5 mg/mL,10 mg/mL, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Furosemide 20 mg/mL svn Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Gent 80 mg/Liter Nasal, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Glutathione 200 mg/mL SVN Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Glutathione 300 mg/1.5 mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Hydroxocobalamin 1mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Hydroxocobalamin 5000IU/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
M-Cobalamin (B12)  Injection 200 mcg, 2000mcg, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
M-Cobalamin 2/Folate 5mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Medroxyprogesterone 150/LID 5 mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Methylcobalamin Injection 1000 mcg/mL, 10000 mcg/mL, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Methylcobalamin Injection 10 mg/mL, 20 mg/mL, 30 mg/mL, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Mupiro/Doxycyc Sinus Rinse, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Alcohol4%/Bupivicaine0.5%  sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Ascorbic Acid 500 mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Cantharitus Multi-Mix Prep, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Benadryl 50mg/2mL Pres-Free Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Calcium Chloride Dihydrate Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Calcium EDTA 300mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Calcium Gluconate 10% Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Cantharidin 0.7% Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Cyancobalamin 2000mcg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Dexpanthanol B5 250mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Dextrose 50% Inj Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
HCG 10,000U/10mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona
Heparin 1000 Unit/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Heparin Sodium 30,000U/30ML Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Hydrochloric Acid 2mg Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Jessners Dermal Solution, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Ketorolac 40mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Lidocaine Injection 1% , 2%, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Magnesium Chloride Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Magnesium Sulfate 50% Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Marcaine 0.24%/Ethanol 4% Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
N.A.C. 20% SVN Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Novarel ''HCG'' 10000U/Vial, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Omnitrope 17.4U/10mL Inj-Kit, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Phenylephrine 500mcg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Podophyllum 40% Topical, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Potassium Chloride 40 mEq/mL Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Procaine HCl Injection 1%, 2%, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Progesterone Cyp Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Pyridoxine B6 100mg Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
PZI 40 Insulin (Human) Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Quad Mix Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Sal-Acid 60% Plaster Paste, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Sermorelin Injection 10mg/10mL,10mg/mL, 20mg/10mL, 9mg/9mL, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Serum Tears 20% Opth, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Sodium Bicarbonate 8.4% Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Squaric Acid 4% Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Super B Comp w/Cyano 3X Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
T.C.A 30% Acid Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Tacrolimus 0.02% Opth Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Test Cyp/Test Prop 1:1 Injection 100mg/mL, 120mg/mL, 150mg/mL, 160mg/mL, 170mg/mL, 200mg/mL, 300mg/mL, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Testost CYP 200mg/mL SUS, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Testosterone Injection 100mg/mL, 200mg/mL, 300mg/mL, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Tev-Tropin (Somatropin) Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Toradol 60mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Testosterone CYP Inj 200 mg/mL, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Tri-Amino OAC 1:1:1 300mg/mL, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Tri-Mix ED Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Tri-Test 1:1:1 300mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Verapamil 120mg/12mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Vitamin B12 (Cyan) Inj 100mcg/mL, 1000mcg/mL, Rx Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Vitamin B-Complex 100 Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
VitB12/VitC/VitB3/VitB9 Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Wilson's Nasal Irrigation Solution, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Hydroxocobalamin 1mg Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
17-Hydroxyprogesterone 250mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Sodium Chloride 0.9% Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Sodium Hydroxide 10% Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
HCG 1000unit/10mL MTU vial, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Lipodissolve 100/50mg Inj Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Super B Complex 3X Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Super B Complex w/Cyano Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Tacrolimus 0.03% Opth Oint, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Triamcin 40mg/mL Susp, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Triamcin40/Lido5 mg/mL Sus, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Tri-Mix LOW ED Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Quad Mix Strong Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Salicylic Acid Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona  85938
Distributed US (nationwide) and the countries of  Canada, Japan, Saudi Arabia, Kuwait, South Africa, Switzerland, France, and Italy.
Model 5001102 MPS Delivery Set w/ arrest agent and additive cassettes, heat exchanger &10 ft. delivery tubing; Model 5001102-AS MPS Delivery Set with 6 ft. delivery tubing; Model 7001102 MPS Low Volume Delivery Set for use with cardiopulmonary bypass equipment.
The products have been found to intermittently exhibit a seal failure during use.
Doria AUTHENTIC ITALIAN GOODNESS, Amaretti BISCUITS, Net Wt. 8.81 oz (250g), UPC 799540801696, BAULI S.p.A Via Verdi, 31 37060 Castel d'Azzano (VR) Stabilimento di Via Pontebbana, 32 Orsago (Treviso) Italia.  PRODUCT OF ITALY
Bauli S.p.A. has initiated a recall due to high levels of Aflatoxin B1
ProTrack Microcatheter.  Model/Catalog Numbers CIC38-145, CIC35-145.   Sterile, single use device intended to be used as a standard infusion wire or as an exchange guide for exchanging guidewires. Coaxial Injectable catheter guide wire. Cardiovascular.
Microcatheter may have circumferential defects (cracks) along its shaft.
Apheresis products, for which the quality control testing for white blood cell count was not performed, were distributed.
IOL Master 5.5: Software versions 7.5 and 7.7; Ophthalmic: used to obtain ocular measurements and perform calculations to allow physicians to determine appropriate IOL power and type for implantation.
IOL Master software versions 7.5 and 7.7 calculation printouts and exported reports can contain the wrong IOL power data.
IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.
DeRoyal sterile custom surgical kits: 1) Emergency CABG Pack Pgybk, ref 89-7859.01 2) Emergency CABG Pack Pgybk, ref 89-7859.02 3) Open Heart Pack A&B Pgybk, ref 89-7750.02 4) Open Heart Pack A&B Pgybk, ref 89-7750.03 5) Intl-Cardiac Surgery Pack A&B Pgybk, ref 89-8514.02 GEO-MED sterile custom surgical kits: 1) Open Heart Pack Pgybk, ref 89-5792.10 2) Open Heart A&B Pgybk, ref 89-7626.02 3) Open Heart A&B Pgybk, ref 89-7626.03 4) Open Heat Pack A&B Pgybk, ref 89-8440.01 5) Open Heart Pack A&B Pgybk, ref 89-8440.02
These custom sterile surgical kits contain the component, ECOLAB ORS Fluid Warming and Slush Drape, which was recalled due to the possibility that the sterile packaging may contain small channels in the seal of the pouch.
Arizona, Arkansas, California, Florida, Georgia, Illinois, Kansas, Kentucky, Massachusetts, Michigan, Minnesota, Missouri, Nevada, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, and Washington.
Melissa's Italian Pine Nuts, 2oz (57g), 12 cartons/case, UPC 0 45255 14351 5   Melissa's Profit Strip Pine Nuts Italy, 2oz (57g), 12 cartons/case, UPC 0 45255 14351 5.
World Variety is recalling Italian Pine Nuts because it has the potential to be contaminated with Salmonella.
Wegman's Italian Classics Pine Nuts, 3oz (85g), 6 cartons/case, UPC 0-77890-24823-2
Nationwide Distribution including the states of AZ, AR, CA, CO, CT, FL, GA, IL, IN, KS, LA, MD, MA, MI, MN, MO, NV, NH, NJ, NY, NC, OH, OK, PA, SC, TN, TX, UT, VA, WA, and WI.
Radiesse (+) Lidocaine Injectable Implant 1.5cc, P/N: 8063M0K1.  Indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds.
The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect.
Distributed in the states of CA, and TX and in the country of   Mexico.
Altrus Thermal Tissue Fusion Energy Sources, Catalog Numbers: 1) 60-9500-120 & 2) 60-9500-INT.  Thermal Ligation and Cutting Energy Source.
Miscalibration of the Energy Source monitoring function, which may incorrectly sense the handpiece temperature as higher than the actual handpiece's temperature. This causes some devices to generate a ''Check Seal'' message with an audible alarm and to stop the heating cycle.
AZ, CA, CT, ID, MA, MD, ME, NC, NJ, NV, NY, OH, OR, PA, SC, UT, VA, and WA.
Kozy Shack is recalling one lot of Kozy Shack Indulgent Recipe Pudding in a Salted Caramel cardboard sleeve because it may contain Vanilla Bean Pudding cups, which contain egg.
Distributed US (nationwide) and the countries of Canada, Japan, Mexico, Russia, and Peru.
Copper NiTi Preformed Archwires; Copper NiTi 40 BAF .016X.022 LO Pk10, Part No. 211-0952.  Intended to provide tooth movement.
Ormco Corporation is recalling Copper NiTi Preformed Archwires because the product transformation temperature as listed on the labeling is incorrect.
Distributed US (nationwide) including the Virgin Islands and South Africa.
PROLARYN Injectable Implant 1.0 cc Gel, Model No. 8602M0K5. A restorable implant material to aid in surgical reconstructions as a space occupying material in laryngeal surgical procedures for vocal fold medialization and augmentation.
PROLARYN PLUS Injectable Implant 1.0 cc Plus Calcium Hydroxlyapatite (CaHA) Injectable Implant, Model No. 8044M0K5. An injectable implant used to treat vocal fold insufficiency.
U-SDN 2 Part Ultra Modified Seldinger Needles, NS/37-0387. All needles were sold in bulk, non-sterile, and intended for further processing. Needles are packaged in zipper-bags, 300 pieces per bag, with shipment occurring in a corrugated cardboard box. Needles consist of a stainless steel cannula with a molded plastic hub. This needle is intended to be placed over the guidewire to enlarge the opening in the vessel.  Vessel dilator, for percutaneous catheterization.
The firm had received a complaint alleging that a medical professional had difficulty inserting a guide wire into a needle
Worldwide Distribution - USA (nationwide) including Puerto Rico and to the countries of : Algeria, Argentina, Armenia, Australia, Austria, Bangladesh, Belarus, Belgium, Bermuda, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, French Polynesia, Georgia, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary , India, Indonesia, Iran, Ireland, Israel, Italy, Japan Jordan, Kazakhstan, Kenya, Kuwait, Korea, Latvia, Luxembourg, Lebanon, Lithuania,  Macedonia, Malaysia, Malta, Martinique, Mauritius , Mexico, Morocco, Netherlands, New Zealand, Norway,Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syria, Trinidad, Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela and Vietnam.
Medtronic InSync III, model 8042, 8042B and 8042U.  Implantable pulse generator pacemaker.
Medtronic has confirmed an issue with InSync III CRT-pacemaker devices related to long-term battery performance.  The root cause is unexpected high battery impedance.
Distribution was nationally to the Continental US.
Virginia Diner, Happy Holidays labeled, Pecan Turtledoves, Chocolate Caramel Pecan Cluster, 10 oz, can, UPC 0 85582 01155 2, 10A Lot: 092915 PNT, Best By: 09 23 16.
757 units were mislabeled and distributed
An unknown quantity of a 757 unit run of Peanut Turtledoves was mislabeled with Pecan Turtledove labels.
Brookshire Brothers LTD-Central Bakery Plant
David's Gourmet Chocolate Chunk Pecan Cookie 10 count NET WT 15 oz (0.94 lb) packed in white cardboard box
Prednisone 20 mg, Tablet, 10-count bottle, Rx only, Mfg by: HIKMA Pharmaceuticals PO BOX 182400 Amman 11118 Jordan. Dist By: West-Ward Pharmaceuticals Corp., Eatentown, NJ 07724 USA, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC 51655-320-53
Labeling: Not elsewhere classified. NDC number is incorrect on the container.