Librax — Class III drug recall D-1034-2016
Terminated recall by Valeant Pharmaceuticals North America LLC, reported 2016-06-22, distributed nationwide. Failed Impurities/Degradation Specifications
| Recall number | D-1034-2016 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Valeant Pharmaceuticals North America LLC, Bridgewater, NJ, United States |
| Recall initiated | 2015-04-18 |
| Classified | 2016-06-16 |
| Reported by FDA | 2016-06-22 |
| Terminated | 2017-06-13 |
| Distributed | Nationwide (US) |
| Quantity | 6,321 bottles |
| Reason classes | specification failure |
| NDC | 00187-4100, 00187-4100-10 |
| Lot numbers | 04/19, 06/16, 14L024P, 15E029P |
Product
Librax (5 mg chlordiazepoxide HCl and 2.5 mg clidinium bromide) capsules, 100-count bottle, Rx Only, Manufactured in Canada by: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7 Canada; Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, NDC 0187-4100-10.
Reason for recall
Failed Impurities/Degradation Specifications
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1034-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.