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Recall Observatory FDA recall evidence

Drug 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.

D-1116-2015

April 17, 2015

Class II

Product summary

Firm
Valeant Pharmaceuticals North America LLC
Event
Event 71328
Status
Terminated
Classification
Class II
Quantity
93,237 Bottles
Official record key
drug-enforcement:D-1116-2015

Official wording

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

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.

Distribution pattern: United States Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out of specification