Why it was recalled
Failed Impurities/Degradation Specifications
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #: 14L024P, Exp 06/16; and 15E029P, Exp 04/19
Where it was sold
Nationwide and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1034-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Apr 18, 2015
- FDA report date
- Jun 22, 2016
- Quantity
- 6,321 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Valeant Pharmaceuticals North America LLC
Original FDA data
Every field from FDA enforcement report D-1034-2016, exactly as published.
Show all FDA fields
- City
- Bridgewater
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 70112
- Address
- 400 Somerset Corporate Blvd
- Code information
- Lot #: 14L024P, Exp 06/16; and 15E029P, Exp 04/19
- Postal code
- 08807-2867
- Report date
- Jun 22, 2016
- Product type
- Drugs
- Recall number
- D-1034-2016
- Classification
- Class III
- Recalling firm
- Valeant Pharmaceuticals North America LLC
- Product quantity
- 6,321 bottles
- Termination date
- Jun 13, 2017
- Reason for recall
- Failed Impurities/Degradation Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Apr 18, 2015
- Initial firm notification
- Letter
- Center classification date
- Jun 16, 2016