Recalls / Class II

Class IID-1116-2015

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.

Affected lot / code info

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.

Why it was recalled

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

Recalling firm

Firm

Valeant Pharmaceuticals North America LLC

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

400 Somerset Corporate Blvd, N/A, Bridgewater, New Jersey 08807-2867

Distribution

Quantity

93,237 Bottles

Distribution pattern

United States Nationwide

Timeline

Recall initiated

2015-04-17

FDA classified

2015-06-08

Posted by FDA

2015-06-17

Terminated

2016-04-12

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1116-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.