Class II · Moderate risk
Ambi 40pse/400gfn/20dm
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
FDA drug recalls in 2013
Every FDA drug recall initiated in 2013, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
2,085 recalls, newest first.
Class II · Moderate risk
Ambi 3brm/30dm/50pse
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class II · Moderate risk
Ambi 3brm/15dm/30pse
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class II · Moderate risk
Ambi 2cpm/15dm/5peh
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class II · Moderate risk
Ambi 25cpd/200gfn
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class II · Moderate risk
Ambi 12.5 Cpd/120gfn/5peh
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class II · Moderate risk
Ambi 12.5 Cpd/100gfn/30pse
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class II · Moderate risk
Ambi 25dph/7.5peh
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class II · Moderate risk
Ambi 20dm100gfn10peh
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class II · Moderate risk
Ambi 15dm/100gfn/5peh
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class II · Moderate risk
Lansoprazole Delayed-release Capsules
Presence of Foreign Tablets/Capsules: Bottles of lansoprazole 30 mg delayed-release capsules may contain topiramate 100 mg tablets.
Class III · Low risk
Methocarbamol 750 mg Tablets
Labeling: Incorrect or missing lot and/or expiration date. The product was mistakenly labeled with an expiration date of 10/16 instead of 01/16.
Class I · High risk
Lactated Ringer's and 5% Dextrose Injection
Non-Sterility: Confirmed customer complaint of product contaminated with mold.
Class III · Low risk
Sodium Sulfacetamide 10% and Sulfur 5% Lotion
Superpotent: Drug product active ingredients were formulated incorrectly (too high) with respect to the label strength.
Class II · Moderate risk
Terazosin Hydrochloride Capsules
Presence of Foreign Tablets/Capsules: Recall is being conducted due to a foreign capsule found in one bottle.
Class III · Low risk
Crest PRO-HEALTH CPC Antigingivitis/Antiplaque Oral Rinse
Cross Contamination with Other Products: Product was mixed with another type of mouth wash.
Class II · Moderate risk
Irinotecan Hydrochloride Injection
Crystallization: Active pharmaceutical ingredient is precipitating in product solution.
Class II · Moderate risk
Medi-bolic Booster Injectable
CGMP Deviations: Pharmaceutical for injection was not manufactured according to Good Manufacturing Procedures.
Class III · Low risk
Syeda (drospirenone and ethinyl estradiol)
Tablet/Capsule Imprinted with Wrong ID; a portion of the tablets could contain the incorrect debossing on one side of the tablet U2 instead of U3.
Class III · Low risk
Wal-Mart Equate Tussin CF Adult Maximum Strength
Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.
Class III · Low risk
Select Brand Cough Control CF Max
Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.
Class III · Low risk
Rite Aid Maximum Strength Tussin Cough & Cold Mucus Relief CF
Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.
Class III · Low risk
Well at Walgreens Wal-Tussin CF Max
Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.
Class II · Moderate risk
Mercuroclear Antiseptic Anesthetic First Aid Helps prevent…
Microbial Contamination of Non-Sterile Product(s): The product has the potential to be contaminated with Bulkholderia gladioli.
Class III · Low risk
Ventavis (iloprost)
Subpotent Drug: OOS (out of specification) assay result at the 12 month stability time point.