Recall Enforment Report D-0913-2018
Recall Details
Multi event Drug Recall Enforcement Report Class III done by Wockhardt Limited, originally initiated on 06-19-2018 for the product 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. The product was recalled due to failed impurities/degradation specifications. The product was distributed nationwide and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number | Recall Initiation Date | Report Date | Recall Classification | Quantity | Product Description | Recall Reason | Status |
|---|---|---|---|---|---|---|---|
| D-0913-2018 | 06-19-2018 | 07-18-2018 | Class III | 17,628 tablets | 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. | Failed Impurities/Degradation Specifications | Terminated |
| D-0912-2018 | 06-19-2018 | 07-18-2018 | Class III | 31,710 tablets | 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. | Failed Impurities/Degradation Specifications | Terminated |