Drug recall
Enalapril Maleate tablets, USP, 5mg, 1000-count bottles, Rx only, Manufactured by: Wockhardt Limited H-14/2…
FDA recall event 77951 · Class III · Wockhardt Usa Inc.
Key facts
| Event ID | 77951 |
|---|---|
| Recall numbers | D-0051-2018 |
| Recalling firm | Wockhardt Usa Inc. |
| Product type | Drugs |
| Products | Enalapril Maleate tablets, USP, 5mg, 1000-count bottles, Rx only, Manufactured by: Wockhardt Limited H-14/2, M.I.D.C. Area, Waluj, Aurangabad, Maharashtra, India, Distributed by: Wockhardt, USA LLC… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed Impurities/Degradation Specifications: 5mg strength being recalled for out of specification results for related compound. |
| Initiation date | Aug 22, 2017 |
| Report date | Nov 1, 2017 |
| Termination date | Feb 27, 2019 |
| City | Parsippany |
| State | NJ |
| Country | United States |
| FEI number | 3003060524 |
At a glance
- 1–9 Products in this recall
- 1–9 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: