April 2019 FDA Recall Divalproex Sodium by Major Pharmaceuticals
D-1583-2019 - cGMP deviations
This Class II drug recall was initiated by Major Pharmaceuticals on April 24, 2019 for the product Divalproex Sodium. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1583-2019
cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
04-24-2019
08-07-2019
828 100-count unit dose cartons
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
MAJOR PHARMACEUTICALS
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
N/A
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
07-16-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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.
Batch or Lot Expiration Information
Lot# M02250 EXP 10/2020.
