FDA-Drug2016-06-22Class III

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.

Valeant Pharmaceuticals North America LLC
Hazard

Failed Impurities/Degradation Specifications

Sold states
Nationwide and Puerto Rico
Affected count
6,321 bottles
Manufactured in
400 Somerset Corporate Blvd, Bridgewater, NJ, United States
Products
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.

Official notice

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

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