Home / Recalls / MAJOR PHARMACEUTICALS / D-1583-2019

D-1583-2019 Class II Terminated

Recalled by MAJOR PHARMACEUTICALS — Livonia, MI

Recall Details

Product Type
Drugs
Report Date
August 7, 2019
Initiation Date
April 24, 2019
Termination Date
July 16, 2020
Voluntary/Mandated
N/A
Product Quantity
828 100-count unit dose cartons

Product Description

DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS, USP Tablets, 250 mg, 100 count-unit dose carton, RX only, Manufactured by Dr. Reddy's Laboratories Ltd. Bachupally - 500 090 India. Distributed by: Major Pharmaceuticals 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152. NDC # 0904-6363-61.

Reason for Recall

cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.

Distribution Pattern

Nationwide in the USA

Code Information

Lot# M02250 EXP 10/2020.

Other recalls by MAJOR PHARMACEUTICALS

  • 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-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)