courtlistener_docket
1 records
Azurity Pharmaceuticals, Inc. v. Appco Pharma LLC
2026-04-08
Federal docket 1:26-cv-00402 (ded); matched party 'Appco Pharma LLC'
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fda
6 records
FDA Drug Recall: Prazosin Hydrochloride Capsules, USP, 1mg, 100-count bottle, Rx Only, Manufactur
2026-04-08
Class II — cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
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FDA Drug Recall: Prazosin Hydrochloride Capsules, USP, 2mg, 100-count bottle, Rx Only, Manufactu
2026-04-08
Class II — cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
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FDA Drug Recall: Prazosin Hydrochloride Capsules, USP, 5mg, 100-count bottle, Rx Only, Manufactur
2026-04-08
Class II — cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
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FDA Drug Recall: Venlafaxine Extended-Release Tablets, 150mg, Rx only, 90 Tablets, Manufactured b
2025-01-29
Class III — Failed Tablet/Capsule Specifications: Missing tab ID on either side of the tablet
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FDA Drug Recall: Ranitidine Capsules 300 mg, 30 count bottles. Rx only, Manufactured by: Appco Ph
2020-01-15
Class II — CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
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FDA Drug Recall: Ranitidine Capsules 150 mg, (a) 60 count bottles (NDC 62559-690-60) , (b) 500 co
2020-01-15
Class II — CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
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fda_adverse
1 records
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