Class III · Low risk Terminated
Librax (5 mg chlordiazepoxide HCl and 2.5 mg clidinium bromide) capsules, 100-count bottle, Rx Only, Manufactured in Canada by…
Reason Failed Impurities/Degradation Specifications
Chlordiazepoxide HCl/Clidinium Bromide capsules, 5 /2.5 mg, 100-count bottle, Rx Only…
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Impurities/Degradation Specifications
What was recalled
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; Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, NDC 68682-409-10.
- Recalling firm
- Valeant Pharmaceuticals North America LLC
- NDC code
- 68682-409-10
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1035-2016
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
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Class II · Moderate risk Terminated
chlordiazePOXIDE HCl, Capsule, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00555015902.
Reason Labeling: Label Mixup: chlordiazePOXIDE HCl, Capsule, 25 mg may have potentially been mislabeled as one of the following drugs: FLECAINIDE ACETATE…
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