D-1034-2016 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- June 22, 2016
- Initiation Date
- April 18, 2015
- Termination Date
- June 13, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6,321 bottles
Product Description
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 Pattern
Nationwide and Puerto Rico
Code Information
Lot #: 14L024P, Exp 06/16; and 15E029P, Exp 04/19