Valeant Recalls Librax Capsules Due to Failed Impurity Specifications
Valeant Pharmaceuticals is recalling specific lots of Librax capsules because they failed impurity and degradation specifications.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Valeant Pharmaceuticals North America LLC is recalling 6,321 bottles of Librax (chlordiazepoxide hydrochloride and clidinium bromide) capsules. The recall involves 100-count bottles of the prescription medication, which is manufactured in Canada and distributed nationwide and in Puerto Rico.
The recall was initiated because the product failed impurities and degradation specifications. The affected lots are 14L024P (expiration date 06/16) and 15E029P (expiration date 04/19). The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.
Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product matches the recalled lots, it should be returned to the pharmacy or point of purchase for a refund or replacement.
The recalled product
- Product
- LIBRAX (CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE)
- Brand
- LIBRAX
- Manufacturer
- Valeant Pharmaceuticals North America LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 6,321
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 (4)
- Lot #: 14L024P
- Exp 06/16
- and 15E029P
- Exp 04/19
UPCs (1)
- 0301874100101
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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