Home / Recalls / Valeant Pharmaceuticals North America LLC / D-1116-2015

D-1116-2015 Class II Terminated

Recalled by Valeant Pharmaceuticals North America LLC — Bridgewater, NJ

Recall Details

Product Type
Drugs
Report Date
June 17, 2015
Initiation Date
April 17, 2015
Termination Date
April 12, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
93,237 Bottles

Product Description

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.

Distribution Pattern

United States Nationwide

Code Information

Lot #: 1309T27; Expiry: 8/15; Lot #: 1309T28, Expiry: 8/15; Lot #: 1311T33, Expiry: 10/15; Lot #: 1311T34, Expiry: 10/15, Lot #: 1312T40, Expiry: 11/15; Lot #: 1312T41, Expiry: 11/15; Lot #: 1403T23, Expiry: 02/16; Lot #: 1403T21, Expiry: 02/16; Lot #: 1405T21, Expiry: 04/16; Lot #:1405T22, Expiry: 04/16.

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