Home / Recalls / Valeant Pharmaceuticals North America LLC / D-1035-2016

D-1035-2016 Class III Terminated

Recalled by Valeant Pharmaceuticals North America LLC — Bridgewater, NJ

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
564,454 bottles

Product Description

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 Pattern

Nationwide and Puerto Rico

Code Information

Lot #: 13G005P, 13G010P, Exp 06/16; 3H029P, 13J048P, 13J049P, 13J050P, Exp 08/17; 14B047P, 14B048P, 14B049P,14C043P, 14C048P, 14C049P, Exp 01/18; 14D048P, 14D053P, 14D054P, Exp 03/18; 14G042P, 14G047P, 14G049P, Exp 5/18; 14J005P, 14J006P, 14J007P, Exp 07/18; 14K114P, 14K115P, 14K116P, Exp 09/18; 15B008P, 158013P, 15B021P, 15C058P, 15C059P, 15C064P, Exp 01/19; 15E037P, 15E038P, Exp 04/19

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