FDA recall D-1583-2019

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.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2019-04-24

Report date

2019-08-07

Termination date

2020-07-16

Voluntary/Mandated

N/A

Location

Livonia, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1583-2019