FDA-Drug2015-06-17Class II
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.
Valeant Pharmaceuticals North America LLC
Hazard
Failed Dissolution Specifications: High out of specification dissolution result at 1 hour time point.
Sold states
United States Nationwide
Affected count
93,237 Bottles
Manufactured in
400 Somerset Corporate Blvd, N/A, Bridgewater, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1116-2015Don't want to check this manually?
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