Appco Pharma recalls
FDA enforcement reports naming Appco Pharma LLC as the recalling firm.
- Recall reports
- 6
- Class I (serious)
- 0
- Most recent report
- Apr 8, 2026
- Apr 8, 2026Prazosin Hydrochloride Capsules, USP, 2mg, 100-count bottle, Rx Only, Manufactured for…Drug · Appco Pharma LLCcGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.Class II
- Apr 8, 2026Prazosin Hydrochloride Capsules, USP, 5mg, 100-count bottle, Rx Only, Manufactured for:…Drug · Appco Pharma LLCcGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.Class II
- Apr 8, 2026Prazosin Hydrochloride Capsules, USP, 1mg, 100-count bottle, Rx Only, Manufactured for:…Drug · Appco Pharma LLCcGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.Class II
- Jan 29, 2025Venlafaxine Extended-Release Tablets, 150mg, Rx only, 90 Tablets, Manufactured by Appco…Drug · Appco Pharma LLCFailed Tablet/Capsule Specifications: Missing tab ID on either side of the tabletClass III
- Jan 15, 2020Ranitidine Capsules 300 mg, 30 count bottlesDrug · Appco Pharma LLCCGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in APIClass II
- Jan 15, 2020Ranitidine Capsules 150 mg, (a) 60 count bottles (NDC 62559-690-60) , (b) 500 count bot…Drug · Appco Pharma LLCCGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in APIClass II