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.

Recall Number: D-1116-2015

Firm: Valeant Pharmaceuticals North America LLC

Classification: Class II

Status: Terminated

Report Date: 20150617

Initiation Date: 20150417

Termination Date: 20160412

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

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.