Recalls / Class III

Class IIID-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.

Affected lot / code info

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

Why it was recalled

Failed Impurities/Degradation Specifications

Recalling firm

Firm

Valeant Pharmaceuticals North America LLC

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

400 Somerset Corporate Blvd, Bridgewater, New Jersey 08807-2867

Distribution

Quantity

564,454 bottles

Distribution pattern

Nationwide and Puerto Rico

Timeline

Recall initiated

2015-04-18

FDA classified

2016-06-16

Posted by FDA

2016-06-22

Terminated

2017-06-13

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1035-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.