FDA recall D-1291-2022

Product

Divalproex Sodium Delayed-Release Tablets, USP 500mg, Rx Only, 100 Tablets, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries, Ltd., Halol-Baroda Highway, Halol- 389 350, Gujarat, India, NDC 62756-798-88.

Reason for recall

Failed Dissolution Specifications: Failure occurred during routine stability testing of dissolution test.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2022-06-27

Report date

2022-08-03

Termination date

2023-05-31

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1291-2022