Valeant Recalls Chlordiazepoxide HCl/Clidinium Bromide Capsules Due to Impurities
Valeant Pharmaceuticals is recalling specific lots of Chlordiazepoxide HCl/Clidinium Bromide capsules because they failed impurities and degradation specifications.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which indicates a low probability of adverse health consequences, and the source text does not report any specific illnesses or injuries.
Plain-English summary
Valeant Pharmaceuticals North America LLC is recalling 564,454 bottles of Chlordiazepoxide HCl/Clidinium Bromide capsules, 5/2.5 mg, 100-count. The product is a prescription-only medication manufactured in Canada by Valeant Pharmaceuticals International, Inc., and manufactured for Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC.
The recall was initiated because the affected lots failed impurities and degradation specifications. The affected lots include 13G005P, 13G010P, 3H029P, 13J048P, 13J049P, 13J050P, 14B047P, 14B048P, 14B049P, 14C043P, 14C048P, 14C049P, 14D048P, 14D053P, 14D054P, 14G042P, 14G047P, 14G049P, 14J005P, 14J006P, 14J007P, 14K114P, 14K115P, 14K116P, 15B008P, 158013P, 15B021P, 15C058P, 15C059P, and 15C064P, with expiration dates ranging from 06/16 to 04/19.
The affected product was distributed nationwide and in Puerto Rico. Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be returned to the pharmacy or healthcare provider for disposal or replacement.
The recalled product
- 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 A
- Manufacturer
- Valeant Pharmaceuticals North America LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 564,454
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Part of a larger recall action
This product is one of 2 recalled by Valeant Pharmaceuticals North America LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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