Drug recall
Chlordiazepoxide HCl/Clidinium Bromide capsules, 5 /2.5 mg, 100-count bottle, Rx Only, Manufactured in Canada…
FDA recall event 70112 · Class III · Valeant Pharmaceuticals North America LLC
Key facts
| Event ID | 70112 |
|---|---|
| Recall numbers | D-1034-2016, D-1035-2016 |
| Recalling firm | Valeant Pharmaceuticals North America LLC |
| Product type | Drugs |
| Products | 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…, 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… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed Impurities/Degradation Specifications |
| Initiation date | Apr 18, 2015 |
| Report date | Jun 22, 2016 |
| Termination date | Jun 13, 2017 |
| City | Bridgewater |
| State | NJ |
| Country | United States |
| FEI number | 3010446985 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: