Valeant Pharmaceuticals North America LLC recalls Nifedipine Extended-Release Tablets, USP, 90 mg, 100 Tablet Bottles, Rx Only. Manufactured for: Teva Pharmaceuticals USA
Recalled June 17, 2015 · FDA recall D-1116-2015 · Valeant Pharmaceuticals North America
Hazard
Failed Dissolution Specifications: High out of specification dissolution result at 1 hour time point. · FDA Class II
Units
93,237 Bottles
Sold at
United States Nationwide
Description
Failed Dissolution Specifications: High out of specification dissolution result at 1 hour time point.
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.
Manufacturer(s)
Valeant Pharmaceuticals North America LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →