Multi-event June 2018 FDA Recall Drug by Wockhardt Limited

This Multi-event Class III drug recall was initiated by Wockhardt Limited on June 19, 2018 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0913-2018 TERMINATED D-0912-2018 TERMINATED

Recall Number: D-0913-2018

Reason for Recall
Failed Impurities/Degradation Specifications
Initiated
06-19-2018
Reported
07-18-2018
Quantity
17,628 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80356
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Wockhardt Limited
Product Type About Product Type
Broad category of product being recalled.
Drugs
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2020
Product Description About Product Description
Full technical description of 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.

Batch or Lot Expiration Information

Batch# DR10447 (Exp: 4/19)
Batch# DR10996 (Exp: 10/19)
Batch# DS10201 (Exp: 2/20); and
Batch# DR10319 (Exp: 3/20).

Recall Number: D-0912-2018

Reason for Recall
Failed Impurities/Degradation Specifications
Initiated
06-19-2018
Reported
07-18-2018
Quantity
31,710 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80356
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Wockhardt Limited
Product Type About Product Type
Broad category of product being recalled.
Drugs
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2020
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration 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).