Drug recall
Enalapril Maleate Tablets USP; 2.5 mg NDC code 64679-923-03. 1000 Tablets HDPE container pack with Non CRC cap…
FDA recall event 80356 · Class III · Wockhardt Limited
Key facts
| Event ID | 80356 |
|---|---|
| Recall numbers | D-0912-2018, D-0913-2018 |
| Recalling firm | Wockhardt Limited |
| Product type | Drugs |
| Products | Enalapril Maleate Tablets USP; 2.5 mg NDC code 64679-923-03. 1000 Tablets HDPE container pack with Non CRC cap and 2 desiccants further packed in E-flute cartons., Enalapril Maleate Tablets USP; 5 mg NDC code 64679-924-03. 1000 Tablets HDPE container pack with Non CRC cap and 2 desiccants further packed in E-flute cartons. |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed Impurities/Degradation Specifications |
| Initiation date | Jun 19, 2018 |
| Report date | Jul 18, 2018 |
| Termination date | Apr 13, 2020 |
| City | Karodi |
| Country | India |
| FEI number | 3005289335 |
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: