Class III · Low risk Terminated
Chlordiazepoxide HCl/Clidinium Bromide capsules
Reason Failed Impurities/Degradation Specifications
Librax
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Impurities/Degradation Specifications
What was recalled
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.
- Recalling firm
- Valeant Pharmaceuticals North America LLC
- NDC code
- 0187-4100-10
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1034-2016
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Chlordiazepoxide recalls
See all
Class II · Moderate risk Terminated
chlordiazePOXIDE HCl
Reason Labeling: Label Mixup: chlordiazePOXIDE HCl, Capsule, 25 mg may have potentially been mislabeled as one of the following drugs: FLECAINIDE ACETATE, Tablet, 50 mg, NDC 65162064110, Pedigree: AD46414_16, EXP: 5/16/2014; CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826, Pedigree: AD49463_1, EXP: 5/16/2014; LACTOBACILLUS GG, Capsule, 0 mg, NDC 49100036374, Pedigree: W003173, EXP: 6/13/2014.
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