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.
Product description
Enalapril Maleate Tablets, USP, 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 0904-5502-61.
Lot numbers, UPCs & expiration codes
Lot #: T-01082, Exp 08/18; DR10445A, Exp 09/18; DR10443A, Exp 12/18; DR10445B, Exp 03/19; DR10725A, Exp 07/19; DS10024A, DS10040A, Exp 10/19.
Where it was sold
Nationwide in the USA and Puerto Rico.
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-0980-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jun 26, 2018
- FDA report date
- Aug 1, 2018
- Quantity
- 5,933 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- MAJOR PHARMACEUTICALS
Original FDA data
Every field from FDA enforcement report D-0980-2018, exactly as published.
Show all FDA fields
- City
- Livonia
- State
- MI
- Status
- Terminated
- Country
- United States
- Event ID
- 80463
- Address
- 17177 N Laurel Park Dr
- Code information
- Lot #: T-01082, Exp 08/18; DR10445A, Exp 09/18; DR10443A, Exp 12/18; DR10445B, Exp 03/19; DR10725A, Exp 07/19; DS10024A, DS10040A, Exp 10/19.
- Postal code
- 48152-2693
- Report date
- Aug 1, 2018
- Product type
- Drugs
- Recall number
- D-0980-2018
- Classification
- Class III
- Recalling firm
- MAJOR PHARMACEUTICALS
- Product quantity
- 5,933 cartons
- Termination date
- Apr 10, 2019
- Reason for recall
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Enalapril Maleate Tablets, USP, 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 0904-5502-61.
- Distribution pattern
- Nationwide in the USA and Puerto Rico.
- Recall initiation date
- Jun 26, 2018
- Center classification date
- Jul 24, 2018