FDA recall D-0228-2018

Product

Divalproex Sodium Delayed Release Tablets USP, 500 mg, 100-count bottle, RX Only, Manufactured by: Unichem Laboratories Ltd. Ind. Area, Meerut Road, Ghaziabad-201 003, India. Marketed By: Unichem Pharmaceuticals (USA), Inc. Hasbrouck Heights, NJ 07604. NDC 29300-140-01

Reason for recall

Cross Contamination With Other Products: metronidazole powder was found in one bottle of Divalproex Sodium.

Distribution

Product was distributed nationwide in the USA.

Key facts

Status

Terminated

Initiation date

2017-12-19

Report date

2018-01-24

Termination date

2018-09-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Hasbrouck Heights, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0228-2018