Drug & medication recalls Moderate risk

Valeant Pharmaceuticals North America LLC recalls Nifedipine Extended-Release Tablets, USP, 90 mg, 100 Tablet Bottles, Rx Only. Manufactured for: Teva Pharmaceuticals US…

Recall date
April 17, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-1116-2015
FDA classification
Class II
Brand / firm
Valeant Pharmaceuticals North America LLC
Sold / distributed
United States Nationwide

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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