Recall Enforment Report D-0991-2018
Recall Details
Multi event Drug Recall Enforcement Report Class III voluntary initiated by Aidarex Pharmaceuticals LLC, originally initiated on 06-27-2018 for the product Enalapril Maleate, USP 5MG, 90-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0693-90 The product was recalled due to out-of-specification results for the enalapril diketopiperazine degradation product during commercial stability.. 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-0991-2018 | 06-27-2018 | 08-01-2018 | Class III | 61, 90-count bottles | Enalapril Maleate, USP 5MG, 90-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0693-90 | Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability. | Terminated |
| D-0992-2018 | 06-27-2018 | 08-01-2018 | Class III | 25, 30-count bottles | Enalapril Maleate, USP 5MG, 30-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0693-30 | Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability. | Terminated |
| D-0990-2018 | 06-27-2018 | 08-01-2018 | Class III | 11, 90-count bottles | Enalapril Maleate, USP 2.5MG, 90-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0977-90 | Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability. | Terminated |
