Reported Jun 17, 2015 · Terminated
Nifedipine Extended-Release Tablets, USP, 90 mg, 100 Tablet Bottles, Rx Only. Manufactured for: Teva Pharmaceuticals…
Valeant Pharmaceuticals North America LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Valeant Pharmaceuticals North America LLC · 400 Somerset Corporate Blvd · Bridgewater, NJ · 08807-2867
Is this the product you have?
- Nifedipine Extended-Release Tablets, USP, 90 mg, 100 Tablet Bottles, Rx Only
- Manufactured forTeva Pharmaceuticals USA Sailorsville, PA 13960
- Manufactured in Canada ByValeant Pharmaceuticals International, Inc. Steinbach, MB R5G 127 Canada
- NDC0093-2059-01
- Lot codes and dates
10 of 10 products
Products covered by this recall # Product as published 1 1309T27 2 Expiry: 8/15 3 Lot #: 1309T28, Expiry: 8/15 4 Lot #: 1311T33, Expiry: 10/15 5 Lot #: 1311T34, Expiry: 10/15, Lot #: 1312T40, Expiry: 11/15 6 Lot #: 1312T41, Expiry: 11/15 7 Lot #: 1403T23, Expiry: 02/16 8 Lot #: 1403T21, Expiry: 02/16 9 Lot #: 1405T21, Expiry: 04/16 10 Lot #:1405T22, Expiry: 04/16. - Amount recalled
- 93,237 Bottles
Where it was sold
- Nationwide
Why it was recalled
Failed Dissolution Specifications: High out of specification dissolution result at 1 hour time point.
This product could cause temporary or reversible health problems — stop using it.
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