Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
MAX Brand BRAZILIAN BEE PROPOLIS, 180 Count Softgels   Product labeling reads in part:''MAX***BRAZILIAN BEE PROPOLIS DIETARY SUPPLEMENT 180 Softgels***6 65176 31465 0***Manufactured For:HealthMax Products Co. Altadena, CA 91001***''.
In response to a FDA inspection, the firm initiated this voluntary recall of various dietary supplements due to the following problems of mislabeling: 1) product named on the label is not actual product contained; 2)ingredients listed are not actual ingredients contained.
Dermamedics Post Procedure Cream, 1 ounce containers which were distributed with a SKU number of DM 1026
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Dermamedics Calm & Correct Cream in 2 oz. containers with SKU number DM1020.
Dermamedics Baby's Relief Calm and Repair Cream in 2 oz. containers with a SKU number of DM1016 and 0.25 containers with a SKU number of PS 1016; and Therametics Baby's Relief Calm and Repair Cream in 2 oz. containers with a SKU number of BR008.
Dermamedics Complexion Repair Topical Rehydrating Emulsion which was distributed in 50 ml containers with a SKU number of DM 1011 and Therametics Complexion Repair Topical Rehydrating Emulsion which was distributed in 50 ml containers with a SKU number of CR002.
Dermamedics Calm and Correct Serum, 2 oz. containers with a SKU number of BB10062 and 4 oz. containers with a SKU number of BB10068.
Dermamedics Post Procedure Cream 1 oz. containers in the Dermamedics Post-Laser Treatment System with a SKU number of DM 1019
Dermamedics Calm and Correct Cream 2 oz. containers in the Dermamedics Post Medical Procedure Kit with a SKU number of SK1005
Dermamedics Complexion Repair Topical Rehydrating Emulsion in 50 ml and 30 ml containers in the Dermamedics Complexion Repair Acne Treatment System Kit with SKU numbers of DM 1013 and DM 1025, respectively; Therametics Complexion Repair Topical Rehydrating Emulsion which was distributed in 50 ml containers with a SKU number of CR002 and in 50 ml containers in the Therametics Complexion Repair Acne Treatment System Kit with a SKU number of CR1005; and in 30 ml containers in the Therametics Complexion Repair Acne Travel Kit with a SKU number of CR1007.
Therametics Complexion Repair Topical Rehydrating Emulsion in 50 ml and 30 ml containers in the Complexion Repair Acne Treatment System Kit and the Complexion Repair Acne Travel Kit with SKU numbers of CR1005 and CR1007, respectively.
triple therapy, LANSOPRAZOLE DR Capsules USP 30mg, CLARITHROMYCIN Tablets USP 500mg, AMOXICILLIN Capsules USP 500mg, 8 count Blister Pack  Lansoprazole DR Capsules USP &  Clarithromycin Tablets USP, MANUFACTURED Israel for Teva Pharmaceuticals USA, Sellersville, PA 18960, Amoxicillin Capsules USP manufactured in Canada, for  Teva Pharmaceuticals USA, Sellersville, PA 18960. NDC# 0093-8055-78
Failed Impurities/Degradation Specifications: This recall is due to out of specification for impurities test results obtained during stability testing for Lansoprazole.
Product was distributed in the following states:  Alabama, Arizona, Colorado, Louisiana, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Mexico, North Dakota, Oklahoma, Texas, Utah, Washington, Wisconsin, and Wyoming
Original Silk Light Soymilk Half Gallon, Distributed by WhiteWave Foods Broomfield, Colorado 80021, UPC 0 25293 60101 7
Use by dates of 06/22/14 and 06/23/14 will be found on the carton's gable top.   06/22 or 23/14 hh:mm 48-0994 EH3-5 1;  06/22 or 23/14 hh:mm 48-0994 EH3-5 2;  06/22 or 23/14 hh:mm 48-0994 EH3-4 3; and  06/22 or 23/14 hh:mm 48-0994 EH3-4 4.      Code breakdown as follows:  6/22/14 and 6/23/14 are the expiration dates;  hh:mm is the manufacturing time stamp and varies across the run;  48-0994 is the manufacturing plant code;  EH3 is the filler model generation; and the  Remaining numbers are filling machine and lane designations
The product has the potential to contain undeclared almondmilk.
FL LA  AR  IA  OH  OH  WI  IL  LA  KS  MT
Dimension Integrated Chemistry Systems intended to measure a variety of analytes in human body fluids.
There is a misassembly issue with the photometer installed on Dimension Integrated Chemistry Systems instruments. Through internal investigation by  Siemens Healthcare Diagnostics has confirmed that a limited number of Dimension photometers were misassembled. These photometers are performing within specifications, but may lead to a shortened life of the source lamp.
Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
Nationwide Distribution including TN, OK, AZ, PA, TX, MO, NY, NC, CA, FL, WA, AL, IN, NH, SD, and OH.
Small Bone Innovations 3.0/4.0mm AutoFIX''  Cannulated Compression Screw System Sets, Implants, and Instruments     Indications for Use: AutoFIX'' cannu lated screws are indicated for the treatment of fractures, non-unions, pseudoarthrosis and degenerative changes as well as corrective osteotom ies geared towards a functionally stable osteosynthesis in small bones.
Small Bone Innovations (SBi) is recalling all lots of 3.0/4.0mm AutoFIX''  Cannulated Compression Screw System Sets, Implants, and Instruments to update the IFU.
Southern California Permanente Medical Group
Blood products, which did not meet the acceptable product specifications for release, were distributed.
Stryker Medical Division of Stryker Corporation
Worldwide Distribution -USA (nationwide) including DC and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI & WV, and the countries of Argentina, Brazil, Canada, Chile, China, EMEA, Greece, Italy, Japan, Korea, Latin America, Mexico, Poland, Singapore, South Africa, Taiwan, and UK.
InTouch Critical Care Bed, Stryker Medical.  Model Numbers 2130, 2131, 2140, 2141, 2151, 2152, 2155, and 2156.
Stryker has received complaints from the field alleging instances where the In Touch beds are hoisted or lifted from the floor and the casters have fallen off. The investigations into these casters have shown that in these cases the caster has broken on the top of the caster stem where the brake rod inserts into the caster. If more than one caster on a unit is damaged, brake functions can be affected by having a reduced holding force
Distribution was made to MO.  There was no government/military/foreign distribution.
Professional Bak-klene All Purpose No-Stick Bakery Spray, packaged in 14-oz. aerosol cans.
4135 1 CAKE 1800 thru 2100  (1800-2100 = military times affected)
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Worldwide Distribution -- USA, including the states of Alabama, Arkansas, Georgia, Illinois, Kentucky, Louisiana, Missouri, Mississippi, New Jersey, South Carolina, Tennessee, Texas, and Virginia; and the country of Canada.
IPM Wound Gel Rx Wound Dressing   IPM Wound Gel is indicated for the management of wound healing.
Potential for microbial contamination of the product.
Blood products, collected from a donor for whom there was no documentation of an arm inspection, were distributed.
Blood product, manufactured without the entire quantity of additive solution, was distributed.
Worldwide Distribution - USA including MT, OR, LA, NE, NC, MN, UT, FL, KY, IL, CA, VA, TX, CO, KS and Internationally to UNITED KInGDOM, CANADA, and SPAIN.
Medtronic Nexdrive Micropositioning Drive. Models Ml-1000 and Ml-2000.  For use in conjunction with the Medtronic Nexframe Stereotactic System for the precise positioning of microelectrodes and implantable leads.  A stereotactic guidance system used in conjunction with Medtronic StealthStation Navigation Systems-image-guided surgery (IGS) systems-for Deep Brain Stimulation (DBS) procedures.
Medtronic is initiating a voluntary recall for the Nexdrive Micropositioning Drive (model Ml-1000 and Ml-2000) due to the potential for misalignment of the Z-stage scale. Using one of these devices for a procedure could result in the microelectrode being inserted to an incorrect target depth.
Nationwide (Continental USA and Puerto Rico).  A portion of the bulk lot was supplied to Pfizer Germany for packaging into blisters for non- USA market.  One of these lots in Germany was placed in stability having acceptable results, therefore are not part of the recall scope.  Only the product distributed within US/PR market (bottles) is in the scope of this recall.
Cardura XL (doxazosin mesylate extended release tablets, 4 mg, 30-count bottle, Rx only, Distributed by Roerig Division of Pfizer Inc., New York, NY 10017,  NDC 0049-2710-30
Failed Impurities/Degradation Specifications: Product from this lot may not meet specifications for a product degradant.
Aspirin DR Enteric Coated Tablets, USP 325 mg, UD 750 tablets (25x30), Dist. By: McKesson Packaging Services a business unit of McKesson Corporation, concord, NC
Failed Dissolution Specification; at the 12 month time interval.
Worldwide Distribution - US including the states of  CA and OH., and the countries of  BRAZIL, CHINA, KOREA  and TAIWAN.
Zimmer Periarticular Locking Plate System Distal Radial Volar Plate Lateral Column (1st generation stainless steel only).  Orthopedic fixation plate.    For temporary internal fixation and stabilization of osteotomies and fractures.
A complaint was received in which it was reported that an 8-hole plate from lot 62276042 had an enlarged hole that is unable to lock the screw, which resulted in the screw head pulling through plate hole.
Direct consignees in state of Washington.
Richards Too Good BBQ Sauce. 12 oz.   Product is packaged in 12 oz tall glass bottles with metal screw caps and black heat resistant tamper seals.
Product bears not codes.   The products being recalled were distributed up to the date of June 17, 2014.
Richards Rubs & Seasonings LLC is recalling Richards Too Good BBQ Sauce, Richards Too Good Hot Sauce and Richards Too Good Teriyaki Sauce because they may have been improperly processed and because they may have the potential to be contaminated with Clostridium botulinum, which can cause botulism, a serious and potentially fatal foodborne illness.
Richards Too Good Hot Sauce. 12 oz.   Product is packaged in 12 oz tall glass bottles with metal screw caps and black heat resistant tamper seals.
Richards Too Good Teriyaki Sauce. 12 oz.   Product is packaged in 12 oz tall glass bottles with metal screw caps and black heat resistant tamper seals.
Worldwide Distribution -- USA, Canada, and Mexico.
CPR Shield With One Way Valve and Barrier Filter, Reorder No. 4921 --- Dynarex label, 100 per case --- Manufactured for: Dynarex Corporation - Made in China.   Used as a physical barrier for mouth to mouth resuscitation.
''THIS SIDE UP'' is on the wrong side of the product. This error poses a potential health hazard if the wrong labeling is followed by caregivers.
Blood products, in which pooled cryo did not meet acceptable product specifications were distributed.
Platelets Pheresis Leukocytes Reduced Irradiated
Blood product, whose integrity was compromised during component preparation (e.g., leaking at sterile connection site), was distributed.
RUSCH, TruLite, One-Piece Disposable Laryngoscope Handle Blade Combination, Non-Sterile, Rx Only, Distributed by: Teleflex Medical.
There is a possibility the handle of the laryngoscope may heat up and melt the end cap.
Worldwide Distribution - USA (Nationwide) and Internationally to: Korea, Kuwait, and Saudi Arabia.
PHAROS Excimer Laser, Model No. EX-308   UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis and leukoderma
RA Medical Systems is recalling the PHAROS EX-308 Excimer Laser because there is a possibility that the laser may calibrate with the iris closed.
GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements.
Therapeutic Care A, B, C, 225cc HDPE Bottles for A,B.  Capsules for C
Product was manufactured and shipped from Chile and stored in Purefruit Chile warehouses located in Marlyland and California.  Product was further distributed  to retail stores nationwide.
Market Pantry Apple; 3.5 oz/12 pk applesauce is packed into a labeled aluminum pouch with plastic screw-on lid and then placed into a labeled cardboard box; product is labeled in part, ''***market pantry Apple Fruit Pouch***NET WT 3.5 OZ (100g)***DISTRIBUTED BY TARGET CORPORATION MINNEAPOLIS, MN 55403***'' UPC Code: 0-85239-20507-5
BEST BY 19 FEB 2015 through BEST BY 28 MAY 2015
Market Pantry (app+app cin) : 63,958 cases (48 pouches/case); Fruty U: 51,105 cases (40 pouches/case); Mother's Choice:  3132 cases (16 pouches/case).
Purefruit Chile S.A. is recalling pouched applesauce due to the possibility of mold.
Market Pantry Apple Cinnamon; 3.5 oz/12 pk applesauce is packed into a labeled aluminum pouch with plastic screw-on lid and then placed into a labeled cardboard box;  product is labeled in part, ''***market pantry Apple Cinnamon Fruit Pouch***NET WT 3.5 OZ (100g)***DISTRIBUTED BY TARGET CORPORATION MINNEAPOLIS, MN 55403***'' UPC Code: 0-85239-20508-2
BEST BY 22 FEB 2015 through BEST BY 30 MAY 2015
fruty U applesauce, apple; 3.5 oz/20 pk applesauce is packed into a labeled aluminum pouch with plastic screw-on lid and then placed into a labeled cardboard box;  product is labeled in part, ''***fruty U APPLE applesauce***NET WEIGHT 3.53 OZ***FRUTY U www.frutyu.com Product of Chile***''   UPC Code: 7804636770367
fruty U applesauce, apple cinnamon; 3.5 oz/20 pk applesauce is packed into a labeled aluminum pouch with plastic screw-on lid and then placed into a labeled cardboard box; product is labeled in part, ''***fruty U APPLE CINNAMON applesauce***NET WEIGHT 3.53 OZ***FRUTY U www.frutyu.com Product of Chile***''   UPC Code: 7804636770374
HyVee applesauce; 3.5 oz applesauce in aluminum pouch with plastic screw-on lid; product is labeled in part, ''***HyVee Mother's Choice Apple organic baby food NET WT 3.5 OZ (99g)***INGREDIENTS:ORGANIC APPLE, ASCORBIC ACID DISTRIBUTED BY HY-VEE, INC WEST DES MOINES, IA 50266 PRODUCT OF CHILE***''   UPC Code: 075450082029
To foodservice  distributors in CA, GA, ID, NC, PA
Malt-O-Meal Frosted Flakes, item number 00955, UPC 42400-00955.  Net Wt. 2.00oz (56g)
Malt-O-Meal Sugar Frosted Flakes Bowls for foodservice may contain Honey and Oat Blenders and are therefore mislabeled.
Whole Foods Caesar Salad Mini Net Wt 4 0z plastic shell
Product labels switched and undeclared allergens not declared  in ingredient statement. Caesar salad contains undeclared tree nuts and Goat Cheese salad undeclared fish
Whole Foods Mesclun Goat Cheese Salad Mini  Net Wt 4 0z plastic shell
Ledgendairy Cheeseworks, LLC DBA Sequatchie Cove Creamery
SEQUATCHIE COVE CREAMERY, CUMBERLAND (cheese), 320 DIXON COVE ROAD, SEQUATCHIE, TN  37374
Sample of cheese taken by FDA was found to contain generic E Coli.
Worldwide Distribution-USA (nationwide) including the states of AL, AK, AZ, CA, FL, GA, IA, IL, KS, MD, MO, MS, NC, NY, OH, PA, SD, TX, VA, VT, WA, and WI, and the countries of Australia, Austria, Belgium, Brazil, Chile, China, Ecuador, France, Germany, Japan, Netherlands, New Zealand, Norway, Qatar, Russia, Spain, Switzerland, Taiwan, United Arab Emirates, and United Kingdom.
Patient Data Manager 2.0  (Content manager 2.0, Patient Browser 4.0, DICOM Viewer 2.0)   Brainlab Digital Lightbox.  A system for the display of medical images.   Model numbers 25100-05 and 25100-06.  The software can transfer images to and from picture archiving and communication systems (PACS), file servers, or removable storage media.
Model/Catalog Numbers: 25100-05 PATIENT DATA MANAGER 2.0.11  25100-06 PATIENT DATA MANAGER 2.0.2.    Software Versions: 2.0.0, 2.0.1, and 2.0.2
The following defects have been identified for data loaded with Patient Data Manager version 2.0 (including subversions 2.0.0, 2.0.1 and 2.0.2):  1) When loading non-square pixel image data with PDM 2.0, the data set is not correctly transferred and displayed in the corresponding Brainlab navigation or planning software. When a data set is loaded, the pixels of the data set are sorted in order to be displayed. For non-square pixels, the pixel width x is different to the pixel height y. Due to a software error in PDM 2.0, the x and y values are swapped, leading to the result that each individual pixel appears rotated by 90 degrees. This results in a distorted display of the image data. The magnitude of distortion may vary, depending on the Pixel Aspect Ratio, the ratio of width and height of a pixel. Accordingly, for some cases the data distortion will be clearly visible on the Brainlab planning or navigation system, e.g. during the review of the data or when performing the initial patient registration. However, if a non-obvious distortion would occur and not be detected during review of the data, the deviation of the information displayed in the planning or navigation software could mislead the user regarding clinical decisions. 2) It has been determined that non-square pixel data is not suitable for dose calculation with the current Brainlab iPlan RT systems. The actual delivered treatment dose might be different from the dose shown in the treatment plan.
Distributed in the states of MI, GA, OH, IL, MO, and IN.
DeRoyal  KNEE ARTHROSCOPY PACK, REF 89-6192.04, 1 Per Pack, Distributed by:  DeRoyal Industries, Inc.; Manufacturer:  DeRoyal Industries, Inc.
The firm distributed surgical kits which contained Irrigation Sets which were subsequently recalled by Hospira.
DeRoyal Cardiac Hypothermia Tray, REF 50-9422.07, 1 Per Pack,  Distributed by:  DeRoyal Industries, Inc.; Made in Guatemala
US Distribution including the states of FL, GA, KY, MD, MS, MT, PA, SC and TX.
Emerald Fiberoptic Blade, Macintosh 4, Teleflex Medical.  A rigid laryngoscope is a device used to examine and visualize a patient's upper airway and aid placement of a tracheal tube.
Product Code: 004434400, Lot number: 02A1402138
Packaging Error: Customers have reported receiving incorrect product. The box labeling indicates the correct product MAC 4 but the contents are incorrect, Miller 4 blades.
Nationwide Distribution including IL NE NY, NH, CD, MI, TX, CA, PA, FL, KS, UT, MN, WI,. MO. and OR.
MC-500 Multicolor Laser Photocoagulator; Distributed by NIDEK Inc.   Manufactured by NIDEK CO., Ltd, Japan.  For use in ophthalmic and retinal procedures.
Laser aperture label was not affixed to device prior to shipment in the US.
Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90-tablets per bottle, Rx Only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC # 59746-339-90
Presence of Foreign Substance: Tablets may contain dark blemishes identified as stainless steel.
Worldwide Distribution - USA (nationwide) and the countries of United Kingdom, Germany, Sweden, Spain, Israel and Denmark.
FlowCOUPLER.   An implantable device that is used to detect blood flow in vessels.  Used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. The FlowCOUPLER System is intended to detect blood flow and confirm vessel patency intra-operatively and post-operatively at the anastomotic site. Baxter Healthcare.
Baxter Healthcare is recalling the FlowCOUPLER Device because there is a possibility that some units may not maintain electrical continuity during handling intra-operatively and post-operatively, resulting in a loss of Doppler signal.  This may result in the inability to monitor anastomotic patency, with the possibility that blood flow may not be appropriately monitored.
Azor Tablets (amlodipine and olmesartan medoxomil) 10 mg*/40 mg, 30 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc. Parsippany, NJ 07054 NDC 65597-113-30
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
Benicar Tablets (olmesartan medoxomil) 20 mg, 30 and 90 count, Rx Only Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-103-30 and  NDC 65597-103-90
Benicar HCT Tablets (olmesartan medoxomil, hydrochlorothiazide) 20 mg/12.5 mg, 30 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-105-30
Tribenzor Tablets (olmesartan medoxomil/amlodipine/hydrochlorothiazide), 40 mg/5 mg*/25 mg 30 count bottles, Rx Only  Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-116-30
Welchol Tablets (colesevelam HCl) 625 mg, 180 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 ---NDC 65597-701-18
Benicar Tablets (olmesartan medoxomil) 40 mg, 30 and 90 count, Rx Only Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-104-30 and 65597-104-90
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping.
Benicar HCT Tablets (olmesartan medoxomil/hydrochlorothiazide) 40 mg/12.5 mg, 30 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-106-30
Benicar HCT Tablets (olmesartan medoxomil/hydrochlorothiazide) 40 mg/25 mg, 30 and 90 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-107-30 and NDC 65597-107-90
Product was sent to two wholsalers/distributors in PA and NY. No product was distributed outside of the US or to government/VA consignees.
Henry Schein Natural Elegance SE Bond Self-Etch Light-Cure Adhesive contains 50 0.125 mL unit dose tips, 50 applicator brushes, and a product insert.
Product Order Number 112-6966; Lot Number C4211-3; UPC Code *+H65811269662O*; Expiration Date September 2015.
Septodont is recalling Self-Etch bond because the material was incorrectly packaged.
Darby Dental Supply Compolite Bond SE Self-Etch/Light-Curing.  This product is used to adhere restorative material to the tooth during restorations.  Package contains 100 0.125 mL unit dose tips, 100 applicator brushes, and a product insert.
Product Order Number 950-9119; Lot Number C4211-3; UPC Code *950-9119*; Expiration Date September 2015.
Worldwide Distribution - USA including AL, AK, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NM, NJ, NY, NC, ND, OH, OR, PA, RI, SC, TN, TX, VT, VA, WA, WV, WI, WY,and France, Canada, Puerto Rico, Guam, Great Britain, Ireland, Australia.
Horizon Medical Imaging   It is a medical image and information management application that is intended to receive, transmit, store, retrieve, display print and process digital medical images, digital medical video, and associated medical information from various medical imaging systems.
The firm has identified a software issue which may cause a discrepancy between the index of images expected by the application, and the actual content of the folder storing the images.
King of Pops Key Lime Pie, frozen flavored pop cycle, Net Wt. 3.2oz., Hand Made by King of Pops, 4845 Chateau Ave., Unit D, Charleston, SC 29405
King of Pops Banana Puddin', frozen flavored pop cycle, Net Wt. 3.2oz., Hand Made by King of Pops, 4845 Chateau Ave., Unit D, Charleston, SC 29405
OXYCODONE HYDROCHLORIDE C II Oral Solution USP, 5 mg/5 mL, 15 mL Vial, Rx only.  Boehringer Ingelheim, Roxane Laboratories. Roxane Laboratories, Inc. Columbus, Ohio 43216. NDC: 0054-0523-41.
Failed Stability Specifications: Out of specification result for preservative sodium benzoate.
Fagron, Phytobase Cream, 500 g, RX only, For prescription compounding Natural self-emulsifying oil-in water vehicle for oil-solvents ingredients. Contains Phytosomes (Plant Oil Bodies), Manufactured by Fagron, Inc. 2400 Pilot Knob Rd, St Paul, MN 55120, NDC 51552-1205-6.
Microbial Contamination of Non-Sterile Products: Fragon is recalling six lots due to the presence of mold.
Fagron, Pentravan Base 2.5 Kg, RX only, For prescription compouning, Oil-in-water emulsion, PLO gel alternative, Preserved and fragrance-free, Manufactured by; Fagron, Inc. 2400 Pilot Knob Rd, St. Paul, MN 55120 NDC 51552-0919-8.
Fagron, Pentravan Plus Base 2.5 Kg, RX only, For prescription compounding, Oil-in-water emulsion base alternative to PLO gel, Added emulsifier ad viscosity-enhancing agent for use with high concentrations of active ingredients.Preserved and fragrance-free, Manufactured by: Fagron, Inc. 2400 Pilot Knob Rd, St. Paul, MN 55120,  NDC 51552-1285-8,
Alprazolam Tablets, USP, 0.25mg, Rx only, 1000 tablets, Sandoz Inc., Princeton, NJ --- NDC 0781-1061-10
Presence of Foreign Substance; tablets may contain stainless steel metal particulates