Amneal Pharmaceuticals of New York, LLC
Amneal Pharmaceuticals of New York, LLC appears in FDA public data with 26 recalls — including 2 Class I (most serious) —, 0 510(k) clearances, 24 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-0477-2024, Class II) was initiated on March 25, 2024.
Summary
- Total Recalls
- 26 (2 Class I)
- 510(k) Clearances
- 0
- Inspections
- 24
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0477-2024 | Class II | Methylergonovine Maleate Tablets, USP, 0.2mg, 12-count bottle, Rx Only, Distributed by: Amneal Pharm | March 25, 2024 |
| D-0442-2024 | Class I | Vancomycin Hydrochloride for Oral Solution, USP, 250 mg per 5 mL, packaged as (a) 80 mL bottle, NDC | March 21, 2024 |
| D-0327-2024 | Class II | Oseltamivir Phosphate for Oral Suspension 6mg/ml, 60 mL (reconstituted) bottle, RX only, Distributed | February 13, 2024 |
| D-0319-2024 | Class II | Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottle, Rx only, Manufactured by: Amnea | January 15, 2024 |
| D-0426-2024 | Class II | Divalproex Sodium Extended-release Tablets, USP 250 mg, Rx Only, 100 tablets, Manufactured by: Amnea | December 26, 2023 |
| D-0090-2024 | Class II | Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amneal Pharmaceuti | October 27, 2023 |
| D-0876-2023 | Class II | Extended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per bottle, Distributed by: A | May 30, 2023 |
| D-0756-2023 | Class III | Methylprednisolone Acetate Injectable Suspension, USP 80 mg/mL, For Intramuscular, Intrasynovial and | May 8, 2023 |
| D-1362-2022 | Class II | Divalproex Sodium Extended Release Tablets, USP, 250 mg, packaged in 100-count bottle, Rx only, Manu | July 27, 2022 |
| D-0234-2022 | Class II | Flocinolone Acetonide 0.01% Topical Oil, Scalp Oil, Rx, packaged in 4 oz. bottle, Distributed by: Am | November 4, 2021 |
| D-0233-2022 | Class II | Flocinolone Acetonide 0.01% Topical Oil, Body Oil, Rx, packaged in 4 oz. bottle, Distributed by: Amn | November 4, 2021 |
| D-1349-2020 | Class II | amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, Rx only, 100 Tablets bottles, | May 29, 2020 |
| D-1345-2020 | Class II | amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx Only, 500 Tablets bottles, M | May 29, 2020 |
| D-1353-2020 | Class II | amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 tablets bottles, Manufact | May 29, 2020 |
| D-1347-2020 | Class II | amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx only, 100 Tablets bottles, M | May 29, 2020 |
| D-1344-2020 | Class II | amneal Metformin Hydrochloride Extended-release Tablets, USP 500 mg Rx Only 90 Tablets bottles, Manu | May 29, 2020 |
| D-1343-2020 | Class II | amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, Rx Only, 100 count bottles, Di | May 29, 2020 |
| D-1351-2020 | Class II | amneal Metformin Hydrochloride Extended-Release Tablets, 500 mg USP, 500 tablets bottles, Rx only, D | May 29, 2020 |
| D-1354-2020 | Class II | amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Rx Only, Distributed by: Amneal | May 29, 2020 |
| D-1352-2020 | Class II | amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 tablets bottles, Distribu | May 29, 2020 |