D-0913-2018 Class III Terminated
FDA drug recall D-0913-2018 was initiated by Wockhardt Limited on June 19, 2018 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications The recall status is terminated (terminated April 13, 2020). Affected quantity: 17,628 tablets.
Recall Details
- Product Type
- Drugs
- Report Date
- July 18, 2018
- Initiation Date
- June 19, 2018
- Termination Date
- April 13, 2020
- Voluntary/Mandated
- Product Quantity
- 17,628 tablets
Product Description
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.
Reason for Recall
Failed Impurities/Degradation Specifications
Distribution Pattern
Nationwide.
Code Information
Batch# DR10447 (Exp: 4/19); Batch# DR10996 (Exp: 10/19); Batch# DS10201 (Exp: 2/20); and Batch# DR10319 (Exp: 3/20).