FDA recall D-1035-2016

Product

Chlordiazepoxide HCl/Clidinium Bromide capsules, 5 /2.5 mg, 100-count bottle, Rx Only, Manufactured in Canada by: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7 Canada; Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, NDC 68682-409-10.

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-1035-2016