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

FDA recall notice · announced June 17, 2015 · Valeant Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Reason for recall

Failed Dissolution Specifications: High out of specification dissolution result at 1 hour time point.

Notes

Distribution: United States Nationwide
Lot/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.
Quantity: 93,237 Bottles
Status: Terminated
Products in this recall event:
- 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 Inte (D-1116-2015)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.