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
Diltiazem HCl CD capsules, 360 mg, 90-count bottles, Rx Only, Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA; By: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7 Canada; NDC 68682-521-01.
Lot numbers, UPCs & expiration codes
Lots: 18J035P, 18K094P, 18K093P, Exp 09/2020
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-0491-2019
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jan 30, 2019
- FDA report date
- Feb 20, 2019
- Quantity
- 23,884 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Valeant Pharmaceuticals North America LLC
Original FDA data
Every field from FDA enforcement report D-0491-2019, 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: 18J035P, 18K094P, 18K093P, Exp 09/2020
- Postal code
- 08807-2867
- Report date
- Feb 20, 2019
- Product type
- Drugs
- Recall number
- D-0491-2019
- Classification
- Class III
- Recalling firm
- Valeant Pharmaceuticals North America LLC
- Product quantity
- 23,884 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
- Diltiazem HCl CD capsules, 360 mg, 90-count bottles, Rx Only, Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA; By: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7 Canada; NDC 68682-521-01.
- 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