FDA recalls, August 2012: 776 published

191 different companies appear this month.

Risk classification: Class I: 219 · Class II: 528 · Class III: 29

Same month, other agencies:CPSC 35 recallsNHTSA 66 recalls

Recalls this month

DateProduct
August 22, 2012DMSO/HEPARIN 50%/20,000U/25ML SOLUTION 100 ML, 25 ML; DMSO/HEPARIN 50%/5000U/50ML SOLUTIO…D-1506-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012Trabecular Metal Reverse Shoulder Liner 40mm, part 00-4309-028-00 - Per surgical tech…Z-2212-2012Zimmer, Inc.
August 22, 2012Crispy Just Baked Punjabi Cookies 800g, 14 cartons/case.F-1938-2012Shah Distributors, Inc
August 22, 2012GLYCERIN 99.5% OPHTHALMIC 10 ML, 5 ML, 7.5 ML; GLYCERIN 100% OPHTHALMIC 15 ML (4 DIFFE…D-1530-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012BUDESONIDE (P.F) NASAL IRRIGATION 0.5MG/500ML SOLUTION 1000 ML; BUDESONIDE (P.F) NASAL I…D-1469-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012VITAMIN K (PHYTONADIONE) 10MG/ML INJECTABLE 1 ML 2 ML 4 ML; VITAMIN K (PHYTONADION…D-1641-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012PANTOTHENIC ACID 1MG/ML INJECTABLE 30 ML (1 PRODUCT)D-1592-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012INSULIN, LO-DOSE (FROM HUMALOG) 10 UNITS/ML INJECTABLE 10 ML (1 PRODUCT)D-1547-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and s…Z-2184-2012AGFA Corp.
August 22, 2012MITOMYCIN/BUPIVACAINE WITH EPI 1:200,000 0. 04MG/0.5% PER 0.3ML SYR INJECTABLE 3 ML (1 P…D-1582-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012FOLIC ACID 10MG/ML INJECTABLE 60 ML (1 PRODUCT)D-1521-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012CALCIUM CHLORIDE DIHYDRATE, P.F. 100MG/ML (10%) INJECTABLE 200 ML, 240 ML, 500 ML; CALCIU…D-1480-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012Neptune 1 Silver Rover, Part 0700-003-000 Stryker Instruments Neptune Rover IFU part 07…Z-2061-2012Stryker Instruments Div. of Stryker Corporation
August 22, 2012POVIDONE-IODINE OPHTHALMIC 5% SOLUTION 10 ML 125 ML 15 ML 40 ML 50 ML; POV…D-1604-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012MORPHINE SULFATE 2MG/ML INJECTABLE 10 ML; MORPHINE SULFATE MDV 10MG/ML INJECTABLE 10 ML …D-1585-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012PENICILLIN G POTASSIUM 10,000U/ML INJECTABLE 1 ML (1 PRODUCT)D-1596-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 201213.5 mm x 50 mm BrainPath Sheath The NICO BrainPath is a family of products that consi…Z-2200-2012Nico Corp.
August 22, 2012PROGESTERONE AQUEOUS 2MG/ML INJECTABLE 3 ML; PROGESTERONE IN COTTONSEED OIL 50MG/ML INJE…D-1608-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012FLUOROURACIL (5-FU) SOLUTION 5% OPHTHALMIC 100 ML; FLUOROURACIL (5-FU) SOLUTION IN ART…D-1520-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012HYDROMORPHONE/CLONIDINE P. F. 120MG/1.3MCG/ML INTRATHECAL 10 ML; HYDROMORPHONE/CLONIDINE …D-1542-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012FORMIX 100MCG / 30MG / 1MG INJECTABLE 10 ML, 10 MLS, 5 ML; FORMIX 100MCG / 30MG / 2MG IN…D-1522-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012Southern Home Pasta Salad Ranch with Bacon, 7.5 oz., UPC 0788002891, 12 packages per caseF-1932-2012Southern Home
August 22, 2012Southern Home Pasta Salad Creamy Parmesan, 6.2 oz., UPC 0788002892, 12 packages per caseF-1933-2012Southern Home
August 22, 2012Alaris Pump Module model 8100. Subsequent product code: FPA The Pump module is inte…Z-2185-2012CareFusion 303, Inc.
August 22, 2012HYALURONIC ACID SODIUM SALT 10MG/ML INJECTABLE 100 ML, 20 ML; HYALURONIC ACID SODIUM SAL…D-1533-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012EDTA DISODIUM SOLUTION 33.6MG/ML (0.1 MOLAR) OPHTHALMIC 15 ML; EDTA CALCIUM DISODIUM (P…D-1512-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012PHENTOLAMINE 10MG/ML INJECTABLE 6 ML; PHENTOLAMINE 1MG/ML INJECTABLE 2 ML 5 ML; PH…D-1597-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012HYPERTONIC SOLUTION IN PRESERVED WATER 10% INJECTABLE 50 ML (1 PRODUCT)D-1545-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012QUADMIX 12MG/1MG/10MCG/150MCG/ML INJECTABLE 10 ML; QUADMIX 15MG/0.5MG/5MCG/100MCG/ML INJ…D-1610-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012CLINDAMYCIN OPHTHALMIC (PF) 20MG/ML (2MG/0.1ML) SOLUTION 2 ML; CLINDAMYCIN PHOSPHATE OPH…D-1486-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012CYCLOSPORINE (A) AQUEOUS (HUMAN) 0.5% OPHTHALMIC 10 ML, 5 ML; CYCLOSPORINE (A) AQUEOUS …D-1494-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012CHORIONIC GONADOTROPIN (STANDARD) - 21 DAY 200 UNIT VIALS KIT 1 KIT; CHORIONIC GONADOTROP…D-1483-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012VERAPAMIL HCL 10MG/ML INJECTABLE 80 ML; VERAPAMIL HCL 20MG/ML INJECTABLE 50 ML; VERAPAM…D-1640-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012BORON 2MG/ML INJECTABLE 40 ML (2 DIFFERENT PRODUCTS)D-1467-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 201200-4309-029-01 - Trabecular Metal Reverse Shoulder Liner 36 mm 65¿¿ Neck Angle Per surgi…Z-2215-2012Zimmer, Inc.
August 22, 2012Derma-Smoothe/FS (Fluocinolone Acetonide) 0.01%, Body Oil, 4 fl. oz. (118.28mL ), Rx only…D-1647-2012Hill Dermaceuticals, Inc.
August 22, 2012RANITIDINE 25MG/ML INJECTABLE 200 ML 480 ML 800 ML (3 DIFFERENT PRODUCTS)D-1612-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012DMPS 250MG/10ML INJECTABLE 20 ML, 30 ML; DMPS 50MG/ML (500MG/10ML) INJECTABLE 10 ML, 5 ML…D-1504-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012TESTOSTERONE CYP/ESTRADIOL CYP 50MG/2MG/ML INJECTABLE 5 ML; TESTOSTERONE CYPIONATE 50MG/…D-1621-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012Neptune Rover Waste Management System, Neptune 2 Ultra Intended for use in the surgical …Z-2064-2012Stryker Instruments Div. of Stryker Corporation
August 22, 2012GE Healthcare Advantage Workstations, Advantage Worksation version 4.2 and 4.3 with Volum…Z-2203-2012GE Healthcare, LLC
August 22, 2012EPINEPHRINE **(25X1ML AMPULS) 1:1000 1MG/ML INJECTABLE 25 ML; EPINEPHRINE HCL SOLUTION 1…D-1514-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012BUPIVACAINE HCL & EPINEPHRINE, P.F. 0.25% / 1:200,000 INJECTABLE 900 ML; BUPIVACAINE HCL …D-1470-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012BUPIVACAINE/SUFENTANIL, P.F. 15MG/150MCG/ML INTRATHECAL 20 ML (1 PRODUCT)D-1479-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012BIMIX 30MG / 4MG INJECTABLE 10 ML, 5 ML; BIMIX 30MG / 5MG INJECTABLE 10 ML; BIMIX 9…D-1466-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012AMINOPHYLLINE 20ML, SDV** 500MG (25MG/ML) INJECTABLE 20 ML (1 PRODUCT)D-1455-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012Carboplatin Injection, 10 mg/mL, a) 5 mL multi-dose vials (NDC 61703-339-18) (NDC 61703-3…D-1648-2012Hospira Inc.
August 22, 2012TAURINE 50MG/ML INJECTABLE 120 ML 30 ML 40 ML 60 ML (4 DIFFEREN…D-1620-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012Sunquest Laboratory SMART & Sunquest Laboratory SMART SelectZ-2216-2012Sunquest Information Systems, Inc.
August 22, 2012IOPAMIDOL 41% INJECTABLE 198 ML 99 ML 50 ML 600 ML 72 ML; IOHEXOL, …D-1549-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab

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