Drug 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.
D-1034-2016
Product summary
- Event
- Event 70112
- Status
- Terminated
- Classification
- Class III
- Quantity
- 6,321 bottles
- Official record key
drug-enforcement:D-1034-2016
Official wording
Reason: Failed Impurities/Degradation Specifications
Code information: Lot #: 14L024P, Exp 06/16; and 15E029P, Exp 04/19
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications