Home / Recalls / MAJOR PHARMACEUTICALS / D-0980-2018

D-0980-2018 Class III Terminated

Recalled by MAJOR PHARMACEUTICALS — Livonia, MI

Recall Details

Product Type
Drugs
Report Date
August 1, 2018
Initiation Date
June 26, 2018
Termination Date
April 10, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5,933 cartons

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.

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.

Distribution Pattern

Nationwide in the USA and Puerto Rico.

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.

Other recalls by MAJOR PHARMACEUTICALS

  • D-1583-2019 Class II — DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS, USP Tablets, 250 mg, 100 count-unit (April 24, 2019)
  • D-1466-2019 Class II — Losartan Potassium Tablets, USP. 50 mg. NDC# 0904-6390-61. Rx only. 100 count Un (January 10, 2019)
  • D-1026-2018 Class II — Doxycycline Hyclate Tablets, USP, 100 mg, Rx Only, 30 tablets, 3 x 10 unit dose (July 30, 2018)
  • D-0966-2018 Class II — Unit Dose Valsartan Tablets, USP, 80 mg. Rx only, Distributed by: Major Pharmac (July 18, 2018)
  • D-0967-2018 Class II — Unit Dose Valsartan Tablets, USP. 160 mg. Rx only.,Distributed by: Major Pharma (July 18, 2018)
  • D-0979-2018 Class III — Enalapril Maleate Tablets, USP, 2.5 mg, 100 Tablets (10 x 10) Unit Dose per cart (June 26, 2018)