FDAClass IIIJune 22, 2016

Chlordiazepoxide HCl/Clidinium Bromide capsules recall: Impurity Out of Spec

Chlordiazepoxide HCl/Clidinium Bromide capsules, 5 /2.5 mg, 100-count bottle, Rx Only, Manufactured in Canada by: Valeant Pharmaceuticals…

Why was Chlordiazepoxide HCl/Clidinium Bromide capsules recalled?

Failed Impurities/Degradation Specifications

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Chlordiazepoxide HCl/Clidinium Bromide capsules, 5 /2.5 mg, 100-count bottle, Rx Only, Manufactured in Canada by: Valeant Pharmaceuticals…
Recalling firm
Valeant Pharmaceuticals North America LLC
Quantity
564,454 bottles
Distribution
Nationwide and Puerto Rico
Recall date
June 22, 2016
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls