Class II · Moderate risk
Alprazolam Orally Disintegrating Tablets
Failed Tablet/Capsule Specifications; partial tablet erosion resulting in tablet weights below specification in some tablets
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
Metformin Hydrochloride USP
CGMP Deviations: The Active Pharmaceutical Ingredient was not manufactured according to current good manufacturing practices.
Class II · Moderate risk
Dexedrine¿
Failed Dissolution Specifications: Out of Specification (OOS) test results for Hour-4 at the 32 month CRT Stability Level.
Class I · High risk
Slim Expert softgel capsules Dietary Supplement. One month…
Marketed Without an Approved NDA/ANDA; product found to contain undeclared sibutramine
Class I · High risk
Lidiy capsules Dietary Supplement. Each bottle contains 30 capsules.
Marketed Without an Approved NDA/ANDA; product found to contain undeclared sibutramine
Class I · High risk
Slim Fortune capsules Dietary Supplement. Each bottle contains 30…
Marketed Without an Approved NDA/ANDA; product found to contain undeclared sibutramine
Class II · Moderate risk
Albuterol Sulfate Inhalation Solution
Lack of Assurance of Sterility: Nephron Pharmaceuticals Corporation conducted a routine periodic aseptic process simulation and discovered bacterial growth in a number of media fill vials, exceeding the allowable limit.
Class III · Low risk
Potassium Chloride
Labeling: Incorrect or Missing Package Insert: the package insert for the potassium chloride 8 mEq and 10 mEq strength instead of the potassium chloride 10 mEq and 20 mEq strength was packaged with the product.
Class III · Low risk
G & W Fluocinolone Acetonide Cream USP 0.025%
Failed Content Uniformity Specifications; at the 18 month time point.
Class I · High risk
Virilis Pro
Marketed without an Approved NDA/ANDA: Dietary supplement may contain amounts of active ingredients found in some FDA-approved drugs for erectile dysfunction (ED) making the dietary supplement an unapproved drug.
Class I · High risk
PHUK Sexual Enhancement Ultimate Pleasure
Marketed without an Approved NDA/ANDA: Dietary supplement may contain amounts of active ingredients found in some FDA-approved drugs for erectile dysfunction (ED) making the dietary supplement an unapproved drug.
Class I · High risk
Prolifta Dietary Supplement Prolifta
Marketed without an Approved NDA/ANDA: Dietary supplement may contain amounts of an active ingredient found in some FDA-approved drugs for erectile dysfunction (ED) making the dietary supplement an unapproved drug.
Class II · Moderate risk
Lamotrigine Tablets
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices
Class II · Moderate risk
Ciprofloxacin Tablets
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices
Class III · Low risk
Hydroxychloroquine Sulfate Tablets
Failed Tablet/Capsule Specifications: Sandoz is recalling one lot of Hydroxychloroquine Sulfate Tablets, USP, 200mg, due to illegibility of the logo on some tablets.
Class II · Moderate risk
Badger Kids Broad Spectrum SPF30 Zinc Oxide Sunscreen Lotion Tangerine & Vanilla
Microbial Contamination of Non-Sterile Products; Selected lots of Badger Baby and Kids Sunscreen Lotion were recalled due to microbial contamination.
Class II · Moderate risk
Badger Baby Broad Spectrum SPF 30 Zinc Oxide Sunscreen Lotion Chamomile & Calendula
Microbial Contamination of Non-Sterile Products; Selected lots of Badger Baby and Kids Sunscreen Lotion were recalled due to microbial contamination.
Class II · Moderate risk
Ondansetron Injection
Presence of Particular Matter: Potential vendor glass issue - glass spiticules (glass strands) were identified during site inspection of the vials.
Class II · Moderate risk
Metoclopramide Injection
Presence of Particulate Matter: Potential vendor glass issue - glass spiticules (glass strands) were identified during site inspection of the vials.
Class II · Moderate risk
Irinotecan Hydrochloride Injection
Superpotent Drug: a recent review of the USP revealed that an incorrect calculation was used to determine the amount of irinotecan to use in formulation which will result in an assay higher than the labeled claim.
Class II · Moderate risk
Irinotecan Hydrochloride Injection
Superpotent Drug: a recent review of the USP revealed that an incorrect calculation was used to determine the amount of irinotecan to use in formulation which will result in an assay higher than the labeled claim.
Class III · Low risk
Ketoconazole Shampoo
Subpotent
Class II · Moderate risk
Next Choice" One Dose Emergency Contraceptive
Failed Tablet/Capsule Specifications: Multiple complaints for push through tablet breakage.
Class III · Low risk
Acanya (Clindamycin Phosphate and Benzoyl Peroxide)
Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being carried out due to an incorrect expiration date assigned to a lot of physicians samples.
Class III · Low risk
Endometrin
Discoloration; due to prolonged heat exposure.