FDA-Drug2019-08-07Class II
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.
MAJOR PHARMACEUTICALS
Hazard
cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
Sold states
Nationwide in the USA
Affected count
828 100-count unit dose cartons
Manufactured in
17177 N Laurel Park Dr, N/A, Livonia, MI, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1583-2019Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief