Recall: D-1583-2019

Class II - Potentially Harmful

Class IIClassification

2019-04-24Initiated

TerminatedStatus

MAJOR PHARMACEUTICALSFirm

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

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

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (N/A). If you take this product, talk to your pharmacist or doctor before stopping it.