FDA Drug recall D-1034-2016
Librax (5 mg chlordiazepoxide HCl and 2.5 mg clidinium bromide) capsules, 100-count bottle, Rx Only, Manufactured in Canada by: Valeant Pha…
- FDA Drug
- Class III
- terminated
- Published 2016-06-22
On 2016-06-22 the FDA classified a Class III recall of Librax (5 mg chlordiazepoxide HCl and 2.5 mg clidinium bromide) capsules, 100-count bottle, Rx Only, Manufactured in Canada by: Valeant Pha… by Valeant Pharmaceuticals North America, citing failed Impurities/Degradation Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1034-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2015-04-18 |
| Published | 2016-06-22 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Valeant Pharmaceuticals North America |
| Distribution | US |
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
Failed Impurities/Degradation Specifications
Identifiers
| ndc | 0187-4100-10 |
|---|---|
| code_info | Lot #: 14L024P, Exp 06/16; and 15E029P, Exp 04/19 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1034-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.