Class II · Moderate risk
Pyridoxine HCL
Lack of Assurance of Sterility
FDA Drug Recalls
18,003 recalls, newest first
Class II · Moderate risk
Mycophenolic Acid Delayed-Release Tablets USP
Failed Dissolution Specifications
Class II · Moderate risk
Vivier Sheer SPF 30 Mineral With Antioxidants
Microbial Contamination of Non-Sterile Product
Class II · Moderate risk
Mupirocin Ointment
Subpotent Drug
Class II · Moderate risk
Barrier Therapy Skin Protectant Cream
Microbial contamination of non-sterile Products -
Class III · Low risk
AcetaZOLAMIDE Tablets
Discoloration
Class II · Moderate risk
TIRZEPATIDE 60 mg/3mL
Lack of Assurance of Sterility
Class II · Moderate risk
TIRZEPATIDE 20 mg/2mL
Lack of Assurance of Sterility
Class II · Moderate risk
Semaglutide / Cyanocobalamin Injection: 2.5/0.5 mg/mL
Lack of Assurance of Sterility
Class II · Moderate risk
SEMAGLUTIDE 10mg/4mL
Lack of Assurance of Sterility
Class II · Moderate risk
SEMAGLUTIDE 5mg/2mL
Lack of Assurance of Sterility
Class II · Moderate risk
Tirzepatide 2 mL
Lack of Assurance of Sterility
Class II · Moderate risk
Semaglutide
Lack of Assurance of Sterility
Class II · Moderate risk
Cefixime for Oral Suspension USP
Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.
Class III · Low risk
Just Right 5000
LABELING: LABEL MIX-UP.
Class II · Moderate risk
Lidocaine HCl Injection
Lack of Assurance of Sterility
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 II · Moderate risk
Timolol Maleate Ophthalmic Solution USP
Defective Container: patients are unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Class II · Moderate risk
Ibuprofen 800mg
Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.
Class II · Moderate risk
Ibuprofen Tablets
Failed Impurities/Degradation Specifications - at 18-month Stability testing
Class II · Moderate risk
Testosterone Gel
Superpotent Drug
Class III · Low risk
Hydrocortisone 1% & Acetic Acid 2% Otic Solution
Failed Impurities/Degradation Specifications: Out-of-specification results obtained for related impurities and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.
Class II · Moderate risk
IBU Ibuprofen Tablets
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
Class II · Moderate risk
IBU Ibuprofen Tablets
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
Class II · Moderate risk
IBU Ibuprofen Tablets
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.