Drug recall D-1034-2016

Class III Terminated reported Jun 22, 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

Lots and codes

Lot #: 14L024P, Exp 06/16; and 15E029P, Exp 04/19

Recall details

Recalling firm
Valeant Pharmaceuticals North America LLC, Bridgewater, NJ
Quantity
6,321 bottles
Distribution
Nationwide and Puerto Rico
Type
Voluntary: Firm initiated
Recall initiated
April 18, 2015
Terminated
June 13, 2017

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