Drug recall
amneal Metformin Hydrochloride Extended-Release Tablets, 500 mg USP, 500 tablets bottles, Rx only, Distributed…
FDA recall event 85781 · Class II · Amneal Pharmaceuticals of New York, LLC
Key facts
| Event ID | 85781 |
|---|---|
| Recall numbers | D-1343-2020, D-1344-2020, D-1345-2020, D-1347-2020, D-1348-2020, D-1349-2020, D-1350-2020, D-1351-2020, D-1352-2020, D-1353-2020, D-1354-2020, D-1393-2020 |
| Recalling firm | Amneal Pharmaceuticals of New York, LLC |
| Product type | Drugs |
| Products | amneal Metformin Hydrochloride Extended-Release Tablets, 500 mg USP, 500 tablets bottles, Rx only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-05, amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 tablets bottles, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-10, amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, 388213, INDIA Distributed by: Amneal…, amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 90 count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-90, amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, Rx Only, 100 count bottles, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-01 and 7 more |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level |
| Initiation date | May 29, 2020 |
| Report date | Jul 1, 2020 |
| City | Brookhaven |
| State | NY |
| Country | United States |
| FEI number | 3005263655 |
At a glance
- 10–99 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: