Nifedipine Extended-Release Tablets recall: Failed Dissolution
Nifedipine Extended-Release Tablets, USP, 90 mg, 100 Tablet Bottles, Rx Only. Manufactured for: Teva Pharmaceuticals USA Sailorsville, PA 13960.…
Why was Nifedipine Extended-Release Tablets recalled?
Failed Dissolution Specifications: High out of specification dissolution result at 1 hour time point.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- Nifedipine Extended-Release Tablets, USP, 90 mg, 100 Tablet Bottles, Rx Only. Manufactured for: Teva Pharmaceuticals USA Sailorsville, PA 13960.…
- Recalling firm
- Valeant Pharmaceuticals North America LLC
- Quantity
- 93,237 Bottles
- Distribution
- United States Nationwide
- Recall date
- June 17, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)