Class III · Low risk
Atropine Sulfate Ophthalmic Solution
Failed Impurities/Degradation Specifications
FDA Drug Recalls
17 recalls · Class III, newest first
Class III · Low risk
Hydralazine HCl Tablets
Failed Impurities/Degradation Specifications; during routine stability testing for impurities.
Class III · Low risk
Triamcinolone Acetonide Cream USP
Subpotent and Superpotent Drug. Out of specification assay results recorded as part of Uniformity of Container test during long-term stability testing.
Class III · Low risk
Just Right 5000
LABELING: LABEL MIX-UP.
Class III · Low risk
Varithena (polidocanol injectable foam)
Defective Delivery System: incorrect silicone oil-free NormJect 10 mL Luer Lock Solo syringes packaged in the pack, instead of the required silicone oil-free NormJect 10 mL Luer Solo syringes (luer slip connection).
Class III · Low risk
Acetaminophen
Label mix-up: Carton incorrectly labeled.
Class III · Low risk
Peg-3350
Defective container: potential for non-sealed pouches which can lead to product leakage.
Class III · Low risk
Dodex Injectable
Subpotent drug: out of specification results
Class III · Low risk
Complete 30C/200C Homeopathic Kit
Labeling: Label Mix-up: Some bottles of Ferrum Phosphoricum 200C were incorrectly labeled as Ferrum Metallicum 200C.
Class III · Low risk
Tivicay PD
Labeling: Incorrect Lot and/or Expiration Date: The carton has incorrect expiration of 2026-MAY*, whereas the correct expiration date, which is on the tablet bottle label, is 2025-APR.
Class III · Low risk
Sodium Sulfacetamide 10% - Sulfur 5% Cleanser
Subpotent drug
Class III · Low risk
Cyclophosphamide for Injection
Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted product is listed as '20 mg per vial.' This information should read: '20 mg per mL'.
Class III · Low risk
Cyclophosphamide for Injection
Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted product is listed as '20 mg per vial.' This information should read: '20 mg per mL'.
Class III · Low risk
Digoxin Tablets
Failed Impurities/Degradation Specifications
Class III · Low risk
Digoxin Tablets
Cross Contamination with Other Products:(mycophenolate mofetil).
Class III · Low risk
Mercaptopurine Tablets
Failed Dissolution Specifications: results slightly under spec at at 9-months.
Class III · Low risk
HydrALAZINE Hydrochloride Tablets
Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related Compounds (Impurities) at the 6-month time point.