Why it was recalled
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Product description
Cardizem CD (diltiazem HCl) capsules, 180 mg, packaged in a) 30-count bottles (NDC 0187-0796-30); and b) 90-count bottles (NDC 0187-0796-42), Rx Only, Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA; By: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7, Canada.
Lot numbers, UPCs & expiration codes
Lots: a) 18J018P, Exp 08/2020; b) 18J029P, Exp 08/2020
Where it was sold
Nationwide in the USA 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-0488-2019
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jan 30, 2019
- FDA report date
- Feb 20, 2019
- Quantity
- 206 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Valeant Pharmaceuticals North America LLC
Original FDA data
Every field from FDA enforcement report D-0488-2019, exactly as published.
Show all FDA fields
- City
- Bridgewater
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 82021
- Address
- 400 Somerset Corporate Blvd
- Code information
- Lots: a) 18J018P, Exp 08/2020; b) 18J029P, Exp 08/2020
- Postal code
- 08807-2867
- Report date
- Feb 20, 2019
- Product type
- Drugs
- Recall number
- D-0488-2019
- Classification
- Class III
- Recalling firm
- Valeant Pharmaceuticals North America LLC
- Product quantity
- 206 bottles
- Termination date
- Jul 8, 2020
- Reason for recall
- Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Cardizem CD (diltiazem HCl) capsules, 180 mg, packaged in a) 30-count bottles (NDC 0187-0796-30); and b) 90-count bottles (NDC 0187-0796-42), Rx Only, Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA; By: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7, Canada.
- Distribution pattern
- Nationwide in the USA and Puerto Rico
- Recall initiation date
- Jan 30, 2019
- Initial firm notification
- Letter
- Center classification date
- Feb 14, 2019