Drug recall
Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 Tablets per bottle, Rx Only, Manufactured…
FDA recall event 87210 · Class II · Nostrum Laboratories Inc
Key facts
| Event ID | 87210 |
|---|---|
| Recall numbers | D-0249-2021 |
| Recalling firm | Nostrum Laboratories Inc |
| Product type | Drugs |
| Products | Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120. NDC: 29033-056-01 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level. |
| Initiation date | Jan 25, 2021 |
| Report date | Feb 10, 2021 |
| City | Kansas City |
| State | MO |
| Country | United States |
| FEI number | 1930436 |
At a glance
- 1–9 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: