FDA recall D-1133-2019

Product

Divalproex Sodium Extended-Release Tablets, USP, 250 mg a) 100-count bottle (NDC 55111-0533-01), b) 500-count bottle (NDC 55111-0533-05), Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally, - 500 090 INDIA

Reason for recall

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

Distribution

Product was distributed to major distributors and retailers who may have further distribute the product throughout the United States.

Key facts

Status

Terminated

Initiation date

2019-04-11

Report date

2019-04-24

Termination date

2020-06-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1133-2019