Why it was recalled
Failed Impurities/Degradation Specifications
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #: 13G005P, 13G010P, Exp 06/16; 3H029P, 13J048P, 13J049P, 13J050P, Exp 08/17; 14B047P, 14B048P, 14B049P,14C043P, 14C048P, 14C049P, Exp 01/18; 14D048P, 14D053P, 14D054P, Exp 03/18; 14G042P, 14G047P, 14G049P, Exp 5/18; 14J005P, 14J006P, 14J007P, Exp 07/18; 14K114P, 14K115P, 14K116P, Exp 09/18; 15B008P, 158013P, 15B021P, 15C058P, 15C059P, 15C064P, Exp 01/19; 15E037P, 15E038P, 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-1035-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Apr 18, 2015
- FDA report date
- Jun 22, 2016
- Quantity
- 564,454 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Valeant Pharmaceuticals North America LLC
Original FDA data
Every field from FDA enforcement report D-1035-2016, 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 #: 13G005P, 13G010P, Exp 06/16; 3H029P, 13J048P, 13J049P, 13J050P, Exp 08/17; 14B047P, 14B048P, 14B049P,14C043P, 14C048P, 14C049P, Exp 01/18; 14D048P, 14D053P, 14D054P, Exp 03/18; 14G042P, 14G047P, 14G049P, Exp 5/18; 14J005P, 14J006P, 14J007P, Exp 07/18; 14K114P, 14K115P, 14K116P, Exp 09/18; 15B008P, 158013P, 15B021P, 15C058P, 15C059P, 15C064P, Exp 01/19; 15E037P, 15E038P, Exp 04/19
- Postal code
- 08807-2867
- Report date
- Jun 22, 2016
- Product type
- Drugs
- Recall number
- D-1035-2016
- Classification
- Class III
- Recalling firm
- Valeant Pharmaceuticals North America LLC
- Product quantity
- 564,454 bottles
- Termination date
- Jun 13, 2017
- Reason for recall
- Failed Impurities/Degradation Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Apr 18, 2015
- Initial firm notification
- Letter
- Center classification date
- Jun 16, 2016