Class II · Moderate risk
Barrier Therapy Skin Protectant Cream
Microbial contamination of non-sterile Products -
FDA Drug Recalls
411 recalls · Class II, newest first
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 II · Moderate risk
Lidocaine HCl Injection
Lack of Assurance of Sterility
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 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.
Class II · Moderate risk
Hand-I-San
CGMP Deviations: sterile water not used for production
Class II · Moderate risk
Rubbing Alcohol
CGMP Deviations: sterile water not used for production
Class II · Moderate risk
Empower Pharmacy
Lack of Assurance of Sterility
Class II · Moderate risk
Indomethacin Extended-Release Capsules
Failed Dissolution Specifications: below specification results
Class II · Moderate risk
Gabapentin Tablets
Presence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were found in bottle of Gabapentin Tablets
Class II · Moderate risk
Progesterone Injection
Presence of Particulate Matter: Complaint received of a glass particle in the vial.
Class II · Moderate risk
Ciprofloxacin ophthalmic solution USP
Defective container: 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
Glenmark
CGMP Deviations