Recalls / Class III
Class IIID-0979-2018
Product
Enalapril Maleate Tablets, USP, 2.5 mg, 100 Tablets (10 x 10) Unit Dose per carton, Rx only, Manufactured by: Wockhardt Limited, H-14/2, M.I.D.C. Area, Waluj, Aurangabad, Maharashtra, India; Distributed by: Wockhardt USA LLC., 20 Waterview Blvd., Parsippany, NJ 07054; Distributed by: MAJOR Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152; NDC 0904-5609-61.
- Affected lot / code info
- Lot #: T-01083, Exp 08/18; DR10447A, Exp 09/18; DS10201A, Exp 07/19; DS10201B, DS10201C, Exp 08/19; DS10319A, Exp 10/19.
Why it was recalled
Failed Impurities/Degradation Specifications: Sub-recall because this repackaged product was recalled by the manufacturing firm, Wockhardt, due to out-of-specification results for the Enalapril DiKetopiperazine degradation product.
Recalling firm
- Firm
- MAJOR PHARMACEUTICALS
- Notification channel
- N/A
- Type
- Voluntary: Firm initiated
- Address
- 17177 N Laurel Park Dr, N/A, Livonia, Michigan 48152-2693
Distribution
- Quantity
- 3,397 cartons
- Distribution pattern
- Nationwide in the USA and Puerto Rico.
Timeline
- Recall initiated
- 2018-06-26
- FDA classified
- 2018-07-24
- Posted by FDA
- 2018-08-01
- Terminated
- 2019-04-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0979-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.