Recalls / Class III
Class IIID-1034-2016
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.
- Brand name
- Librax
- Generic name
- Chlordiazepoxide Hydrochloride And Clidinium Bromide
- Active ingredients
- Chlordiazepoxide Hydrochloride, Clidinium Bromide
- Route
- Oral
- NDC
- 0187-4100
- FDA application
- NDA012750
- Affected lot / code info
- Lot #: 14L024P, Exp 06/16; and 15E029P, Exp 04/19
Why it was recalled
Failed Impurities/Degradation Specifications
Recalling firm
- Firm
- Valeant Pharmaceuticals North America LLC
- Manufacturer
- Bausch Health US, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Somerset Corporate Blvd, Bridgewater, New Jersey 08807-2867
Distribution
- Quantity
- 6,321 bottles
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2015-04-18
- FDA classified
- 2016-06-16
- Posted by FDA
- 2016-06-22
- Terminated
- 2017-06-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1034-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.