Drug recall
Loxapine Capsules, USP 25 mg, Rx Only, 100-count bottles, NDC 0378-7025-01
FDA recall event 79955 · Class II · Mylan Pharmaceuticals Inc.
Key facts
| Event ID | 79955 |
|---|---|
| Recall numbers | D-0824-2018, D-0825-2018 |
| Recalling firm | Mylan Pharmaceuticals Inc. |
| Product type | Drugs |
| Products | Loxapine Capsules, USP 25 mg, Rx Only, 100-count bottles, NDC 0378-7025-01, Loxapine Capsules, USP 50 mg, Rx Only, 100-count bottles, NDC 0378-7050-01 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | CGMP Deviations |
| Initiation date | Apr 24, 2018 |
| Report date | May 30, 2018 |
| Termination date | Aug 14, 2019 |
| 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: