Drug and pharmaceutical recalls
17747 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2013-08-21FDA-DrugBracco Diagnostics IncClass IIGastrografin (Diatrizoate Meglumine and Diatrizoate Sodium Solution), USP, 37% Organically Bound Iodine, 120 ml bottle, Rx only, Manufactured for Bracco Diagnostics Inc. Princeton, NJ 08543 by Therapex, Division of E-Z-EM Canada Inc. Anjou Quebec H1J2Z4, Canada, NDC 0270-0445-40
Presence of foreign substance: One lot of the product may contain black foreign particles
- 2013-08-21FDA-DrugDr. Reddy's Laboratories, Inc.Class IIRanitidine Hydrochloride Tablets, USP, 150 mg, OTC, a) Equate brand Maximum Strength Acid Reducer, 65 count bottle Dist. By: Wal-Mart Stores, Inc., Bentonville, AR 72710, NDC 49035-404-61 b)Equaline brand maximum strength heartburn relief, , DISTRIBUTED BY SUPERVALU INC., EDEN PRAIRIE, MN 55344, NDC 41163-404-61, c)Wal-Zan brand 150, MAXIMUM STRENGTH, 24 count bottlle, DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD., DEERFIELD, IL 63015, NDC 0363-0404-34
Microbial Contamination of Non-Sterile Products: A lot of raw material used in the manufacture of Ranitidine was positive for Pseudomonas sp.
- 2013-08-21FDA-DrugWest-Ward Pharmaceutical Corp.Class IIBelladonna Alkaloids with Phenobarbital Tablets, 1000 count (NDC 0143-1140-10) and 5000 count (NDC 0143-1140-51) PET bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp., Eatontown, N.J., 07724.
Presence of Foreign Substance: black specks comprised of degraded organic material found on tablets
- 2013-08-21FDA-DrugBoehringer Ingelheim Roxane IncClass IIIPrednisone Tablet USP, 20 mg tablets, packaged in blisters of ten (10) tablets per blister card, ten blister cards per carton, Roxanne, Columbus, OH --- NDC 0054-0018-20
Labeling: Missing Label; missing label on blister card
- 2013-08-21FDA-DrugPallimed SolutionsClass IIVerapamil Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
- 2013-08-21FDA-DrugPallimed SolutionsClass IIVancomycin Ophthalmic PF, compounded by Pallimed Solutions Pharmacy, Wobrun, MA
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
- 2013-08-21FDA-DrugPallimed SolutionsClass IITrimix Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
- 2013-08-21FDA-DrugPallimed SolutionsClass IITestosterone Cypionate Injection,compounded by Pallimed Solutions Pharmacy, Woburn, MA
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
- 2013-08-21FDA-DrugPallimed SolutionsClass IITestosterone Cypionate/Propionate Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
- 2013-08-21FDA-DrugPallimed SolutionsClass IITestosterone Cypionate/Testosterone Enanthate Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
- 2013-08-21FDA-DrugPallimed SolutionsClass IITacrolimus Ophthalmic, Pallimed Solutions Pharmacy, Woburn, MA
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
- 2013-08-21FDA-DrugPallimed SolutionsClass IIQuadmix Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
- 2013-08-21FDA-DrugPallimed SolutionsClass IINandrolone Decanoate Injectable, compounded by Pallimed Solutions Pharmacy, Woburn, MA
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
- 2013-08-21FDA-DrugPallimed SolutionsClass IIMIC with B6 and B12, compounded by Pallimed Solutions Pharmacy, Woburn, MA
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
- 2013-08-21FDA-DrugPallimed SolutionsClass IIMethylcobalamin PF, compounded by Pallimed Solutions Pharmacy, Woburn, MA
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
- 2013-08-21FDA-DrugPallimed SolutionsClass IIHydroxyprogesterone CAPR.(G.S.), compounded by Pallimed Solutions Pharmacy, Woburn MA
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
- 2013-08-21FDA-DrugPallimed SolutionsClass IIHCG Chorionic Gonadotropin, compounded by Pallimed Solutions Pharmacy, Woburn, MA
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
- 2013-08-21FDA-DrugPallimed SolutionsClass IIGentamicin Sulfate Irrigation, compounded by Pallimed Solutions Pharmacy, Woburn, MA
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
- 2013-08-21FDA-DrugPallimed SolutionsClass IIDMSO Aqueous Irrigation 50%, compounded by Pallimed Solutions Pharmacy, Woburn, MA
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
- 2013-08-21FDA-DrugPallimed SolutionsClass IIDexamethasone PF, compounded by Pallimed Solutions Pharmacy, Woburn, MA
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
- 2013-08-21FDA-DrugPallimed SolutionsClass IIDiazepam Injectable, compounded by Pallimed Solutions Pharmacy, Woburn, MA
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
- 2013-08-21FDA-DrugPallimed SolutionsClass IICyclosporine Ophthalmic, compounded by Pallimed Solutions Pharmacy, Woburn, MA
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
- 2013-08-21FDA-DrugPallimed SolutionsClass IICidofovir Opthalmic Solution, compounded by Pallimed Solutions Pharmacy, Woburn, MA
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
- 2013-08-21FDA-DrugPallimed SolutionsClass IIBuprenorphine HCl Veterinary Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
- 2013-08-21FDA-DrugPallimed SolutionsClass IIBiMix Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
- 2013-08-21FDA-DrugPallimed SolutionsClass IIBacteriostatic Water for Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
- 2013-08-21FDA-DrugPallimed SolutionsClass IIAtropine Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
- 2013-08-21FDA-DrugPallimed SolutionsClass IIAlprostadil IN NS Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
- 2013-08-21FDA-DrugPallimed SolutionsClass IIAcetylcysteine Ophthalmic Solution, compounded by Pallimed Solutions Pharmacy, Woburn, MA
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
- 2013-08-14FDA-DrugAmerican Health PackagingClass IIZolpidem Tartrate Tablets 5 mg, 10 tablets per blister, 10 blisters per carton, 100 cartons per box, Rx Only, Manufactured for Wockhardt USA LLC., Parsippany, NJ 07054 by Wockhardt Limited, Mumbai, India, NDC 68084-225-01
Unit Dose Mispackaging: This recall event is due to a random undetected packaging issue which could increase the potential for a small number of individual unit dose blisters to be packed with more than one tablet.
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