Home / Recalls / MAJOR PHARMACEUTICALS / D-0966-2018

D-0966-2018 Class II Terminated

Recalled by MAJOR PHARMACEUTICALS — Livonia, MI

Recall Details

Product Type
Drugs
Report Date
August 1, 2018
Initiation Date
July 18, 2018
Termination Date
October 2, 2022
Voluntary/Mandated
N/A
Product Quantity
5,464 cartons

Product Description

Unit Dose Valsartan Tablets, USP, 80 mg. Rx only, Distributed by: Major Pharmaceuticals, Livonia, MI 48152, NDC# 0904-6594-61.

Reason for Recall

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Distribution Pattern

Nationwide.

Code Information

Major Label Unit Dose 10 x 10 Cartons 80 mg Item # 302086. Lot# T-01270 (Expiry: 7/18). Lot# T-01466 (Expiry: 7/18). Lot# T-01500 (Expiry:2/19). Lot# T-01596 (Expiry: 2/19). Lot# T-01625 (Expiry: 2/19). Lot# T-01712 (Expiry: 2/19). Lot# T-01795 (5/19). Lot# T-01807 (Expiry: 5/19).

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-0967-2018 Class II — Unit Dose Valsartan Tablets, USP. 160 mg. Rx only.,Distributed by: Major Pharma (July 18, 2018)
  • D-0980-2018 Class III — Enalapril Maleate Tablets, USP, 5 mg, 100 Tablets (10 x 10) Unit Dose per carton (June 26, 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)