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.
Recall initiated: 20150417
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated