Why it was recalled
Failed Dissolution Specifications: High out of specification dissolution result at 1 hour time point.
Product description
Nifedipine Extended-Release Tablets, USP, 90 mg, 100 Tablet Bottles, Rx Only. Manufactured for: Teva Pharmaceuticals USA Sailorsville, PA 13960. Manufactured in Canada By: Valeant Pharmaceuticals International, Inc. Steinbach, MB R5G 127 Canada. NDC: 0093-2059-01.
Lot numbers, UPCs & expiration codes
Lot #: 1309T27; Expiry: 8/15; Lot #: 1309T28, Expiry: 8/15; Lot #: 1311T33, Expiry: 10/15; Lot #: 1311T34, Expiry: 10/15, Lot #: 1312T40, Expiry: 11/15; Lot #: 1312T41, Expiry: 11/15; Lot #: 1403T23, Expiry: 02/16; Lot #: 1403T21, Expiry: 02/16; Lot #: 1405T21, Expiry: 04/16; Lot #:1405T22, Expiry: 04/16.
Where it was sold
United States Nationwide
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-1116-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 17, 2015
- FDA report date
- Jun 17, 2015
- Quantity
- 93,237 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Valeant Pharmaceuticals North America LLC
Original FDA data
Every field from FDA enforcement report D-1116-2015, exactly as published.
Show all FDA fields
- City
- Bridgewater
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 71328
- Address
- 400 Somerset Corporate Blvd
- Code information
- Lot #: 1309T27; Expiry: 8/15; Lot #: 1309T28, Expiry: 8/15; Lot #: 1311T33, Expiry: 10/15; Lot #: 1311T34, Expiry: 10/15, Lot #: 1312T40, Expiry: 11/15; Lot #: 1312T41, Expiry: 11/15; Lot #: 1403T23, Expiry: 02/16; Lot #: 1403T21, Expiry: 02/16; Lot #: 1405T21, Expiry: 04/16; Lot #:1405T22, Expiry: 04/16.
- Postal code
- 08807-2867
- Report date
- Jun 17, 2015
- Product type
- Drugs
- Recall number
- D-1116-2015
- Classification
- Class II
- Recalling firm
- Valeant Pharmaceuticals North America LLC
- Product quantity
- 93,237 Bottles
- Termination date
- Apr 12, 2016
- Reason for recall
- Failed Dissolution Specifications: High out of specification dissolution result at 1 hour time point.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Nifedipine Extended-Release Tablets, USP, 90 mg, 100 Tablet Bottles, Rx Only. Manufactured for: Teva Pharmaceuticals USA Sailorsville, PA 13960. Manufactured in Canada By: Valeant Pharmaceuticals International, Inc. Steinbach, MB R5G 127 Canada. NDC: 0093-2059-01.
- Distribution pattern
- United States Nationwide
- Recall initiation date
- Apr 17, 2015
- Initial firm notification
- Letter
- Center classification date
- Jun 8, 2015