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-0913-201806-19-201807-18-2018Class III17,628 tabletsEnalapril 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 SpecificationsTerminated
D-0912-201806-19-201807-18-2018Class III31,710 tabletsEnalapril 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 SpecificationsTerminated