FDA recall D-1034-2016

Product

Librax (5 mg chlordiazepoxide HCl and 2.5 mg clidinium bromide) capsules, 100-count bottle, Rx Only, Manufactured in Canada by: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7 Canada; Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, NDC 0187-4100-10.

Reason for recall

Failed Impurities/Degradation Specifications

Distribution

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2015-04-18

Report date

2016-06-22

Termination date

2017-06-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bridgewater, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1034-2016