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Amneal Pharmaceuticals of New York, LLC

FDA Regulatory Profile

Summary

Total Recalls
26 (2 Class I)
510(k) Clearances
0
Inspections
24
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0477-2024Class IIMethylergonovine Maleate Tablets, USP, 0.2mg, 12-count bottle, Rx Only, Distributed by: Amneal PharmMarch 25, 2024
D-0442-2024Class IVancomycin Hydrochloride for Oral Solution, USP, 250 mg per 5 mL, packaged as (a) 80 mL bottle, NDC March 21, 2024
D-0327-2024Class IIOseltamivir Phosphate for Oral Suspension 6mg/ml, 60 mL (reconstituted) bottle, RX only, DistributedFebruary 13, 2024
D-0319-2024Class IIPhenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottle, Rx only, Manufactured by: AmneaJanuary 15, 2024
D-0426-2024Class IIDivalproex Sodium Extended-release Tablets, USP 250 mg, Rx Only, 100 tablets, Manufactured by: AmneaDecember 26, 2023
D-0090-2024Class IIExtended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amneal PharmaceutiOctober 27, 2023
D-0876-2023Class IIExtended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per bottle, Distributed by: AMay 30, 2023
D-0756-2023Class IIIMethylprednisolone Acetate Injectable Suspension, USP 80 mg/mL, For Intramuscular, Intrasynovial andMay 8, 2023
D-1362-2022Class IIDivalproex Sodium Extended Release Tablets, USP, 250 mg, packaged in 100-count bottle, Rx only, ManuJuly 27, 2022
D-0233-2022Class IIFlocinolone Acetonide 0.01% Topical Oil, Body Oil, Rx, packaged in 4 oz. bottle, Distributed by: AmnNovember 4, 2021
D-0234-2022Class IIFlocinolone Acetonide 0.01% Topical Oil, Scalp Oil, Rx, packaged in 4 oz. bottle, Distributed by: AmNovember 4, 2021
D-1345-2020Class IIamneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx Only, 500 Tablets bottles, MMay 29, 2020
D-1343-2020Class IIamneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, Rx Only, 100 count bottles, DiMay 29, 2020
D-1348-2020Class IIamneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg Rx only 100 Tablets bottles, DiMay 29, 2020
D-1350-2020Class IIamneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Distributed by: Amneal PharmaceuMay 29, 2020
D-1349-2020Class IIamneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, Rx only, 100 Tablets bottles, May 29, 2020
D-1351-2020Class IIamneal Metformin Hydrochloride Extended-Release Tablets, 500 mg USP, 500 tablets bottles, Rx only, DMay 29, 2020
D-1353-2020Class IIamneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 tablets bottles, ManufactMay 29, 2020
D-1347-2020Class IIamneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx only, 100 Tablets bottles, MMay 29, 2020
D-1344-2020Class IIamneal Metformin Hydrochloride Extended-release Tablets, USP 500 mg Rx Only 90 Tablets bottles, ManuMay 29, 2020