VCF Vaginal Contraceptive Film (nonoxynol-9, 28%), package in a carton with 9 single films, Distributed By: Apothecus Pharmaceutical Corp, Ronkonkoma, NY 11779, NDC 52925-112-01
Apothecus Pharmaceutical
cGMP Diviations
💊 Drugs • 3,200 recalls
Apothecus Pharmaceutical
cGMP Diviations
Super Chill Products
Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Optikem International
Lack of Assurance of Sterility
Contract Pharmaceuticals Limited Canada
Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Lack of Assurance of Sterility
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Lack of Assurance of Sterility
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Lack of Assurance of Sterility
Neptune Resources
Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
CGMP Deviations
Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company
Chemical Contamination; presence of benzene.
Neptune Resources
Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Kilitch Healthcare India Limited
Non-Sterility
Kilitch Healthcare India Limited
Non-Sterility
Kilitch Healthcare India Limited
Non-Sterility
Kilitch Healthcare India Limited
Non-Sterility