Drug recall D-1583-2019

Class II Terminated reported Aug 7, 2019

Product

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.

Lots and codes

Lot# M02250 EXP 10/2020.

Recall details

Recalling firm
MAJOR PHARMACEUTICALS, Livonia, MI
Quantity
828 100-count unit dose cartons
Distribution
Nationwide in the USA
Type
N/A
Recall initiated
April 24, 2019
Terminated
July 16, 2020

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