Drug recall
Nizatidine Capsules, USP 150 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5150-91.
FDA recall event 84607 · Class II · Mylan Pharmaceuticals Inc.
Key facts
| Event ID | 84607 |
|---|---|
| Recall numbers | D-0791-2020, D-0792-2020 |
| Recalling firm | Mylan Pharmaceuticals Inc. |
| Product type | Drugs |
| Products | Nizatidine Capsules, USP 150 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5150-91., Nizatidine Capsules, USP 300 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5300-93. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine. |
| Initiation date | Jan 7, 2020 |
| Report date | Jan 29, 2020 |
| Termination date | May 19, 2021 |
| City | Morgantown |
| State | WV |
| Country | United States |
| FEI number | 1110315 |
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: