Every FDA drug recall initiated in 2012, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
534 recalls, newest first.
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Labeling: Presence of Undeclared Additive: Medicated lotion soap produced and distributed by the recalling firm contains the unapproved ingredient, Red Dye #15. This dye is not approved for use in food, drugs or cosmetics.
Marketed Without an Approved NDA/ANDA: These products found to contain undeclared tadalafil. Tadalafil is an FDA-approved drug for the treatment of male Erectile Dysfunction (ED), making these products unapproved new drugs.
Presence of Foreign Substance: Recall is being initiated due to the presence of a foreign particle identified from a customer complaint.
Defective Container; damaged blister units
Tablet Thickness: Potential for some tablets not conforming to weight specifications (under and over weight)
CGMP Deviations: There is potential that Abbott's third party manufacturer, Hospira, may have applied a foreign (incorrect) stopper to vials in a specific lot of Zemplar Injection.
Superpotent (Single Ingredient) Drug: Some of the prefilled cartridge units have been found to be overfilled and contain more than the 1 mL labeled fill volume.
Superpotent; benzocaine
Impurities/Degradation Products: The product was found to contain a slightly out of specification level of bromides, exceeding the bromides limit for USP Sodium Chloride.
Subpotent; fluocinolone acetonide
Subpotent; fluocinolone acetonide
Cross Contamination w/Other Products: This active pharmaceutical ingredient is being recalled due to cross contamination with another product.
Adulterated Presence of Foreign Tablets: Customer complaint that some Endocet 10 mg/325 mg tablets were found mixed in a bottle with Endocet 10 mg/650 mg tablets.
Subpotent Drug: Salicylic acid is subpotent.
Subpotent Drug: Salicylic acid is subpotent.
Subpotent Drug: Salicylic acid is subpotent.
Subpotent Drug: Salicylic acid is subpotent.
Subpotent Drug: Salicylic acid is subpotent.
Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.