Drug product
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.
D-1116-2015
Product summary
- Event
- Event 71328
- Status
- Terminated
- Classification
- Class II
- Quantity
- 93,237 Bottles
- Official record key
drug-enforcement:D-1116-2015
Official wording
Reason: Failed Dissolution Specifications: High out of specification dissolution result at 1 hour time point.
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.
Distribution pattern: United States Nationwide
Derived failure modes
-
Potency or specification failure
out of specification