Why it was recalled
Failed Impurities/Degradation Specifications
Product description
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.
Lot numbers, UPCs & expiration codes
Batch# DR10445 (Exp: 4/19); Batch# DR10637 (Exp: 5/19); Batch# DR10646 (Exp: 5/19); Batch# DR10647 (Exp: 5/19); Batch# DR10725 (Exp: 7/19); Batch# DR10755 (Exp: 7/19); Batch# DR10811 (Exp: 9/19); Batch# DS10040 (Exp: 12/19); Batch# DS10041 (Exp: 12/19); Batch# DS10024 (Exp: 12/19); and Batch# DS10048 (Exp: 12/19).
Where it was sold
Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0912-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jun 19, 2018
- FDA report date
- Jul 18, 2018
- Quantity
- 31,710 tablets
- Recalling firm
- Wockhardt Limited
Original FDA data
Every field from FDA enforcement report D-0912-2018, exactly as published.
Show all FDA fields
- City
- Karodi
- Status
- Terminated
- Country
- India
- Event ID
- 80356
- Address
- H - 14/2 Plot
- Address (line 2)
- Biotech Park
- Code information
- Batch# DR10445 (Exp: 4/19); Batch# DR10637 (Exp: 5/19); Batch# DR10646 (Exp: 5/19); Batch# DR10647 (Exp: 5/19); Batch# DR10725 (Exp: 7/19); Batch# DR10755 (Exp: 7/19); Batch# DR10811 (Exp: 9/19); Batch# DS10040 (Exp: 12/19); Batch# DS10041 (Exp: 12/19); Batch# DS10024 (Exp: 12/19); and Batch# DS10048 (Exp: 12/19).
- Report date
- Jul 18, 2018
- Product type
- Drugs
- Recall number
- D-0912-2018
- Classification
- Class III
- Recalling firm
- Wockhardt Limited
- Product quantity
- 31,710 tablets
- Termination date
- Apr 13, 2020
- Reason for recall
- Failed Impurities/Degradation Specifications
- Product description
- 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.
- Distribution pattern
- Nationwide.
- Recall initiation date
- Jun 19, 2018
- Center classification date
- Jul 9, 2018