QUETIAPINE Fumarate Tablets 25mg 100 Tablets recall: Failed Dissolution
QUETIAPINE Fumarate Tablets 25mg 100 Tablets (10x10) Blister card, Rx, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-530-01
Why was QUETIAPINE Fumarate Tablets 25mg 100 Tablets recalled?
Failed Dissolution Test Requirements: During analysis of long term stability studies at 3 months time point, an OOS was reported for Quetiapine Fumarate Tablets, 25 mg.
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 122600 Exp. 03/14
- Product
- QUETIAPINE Fumarate Tablets 25mg 100 Tablets (10x10) Blister card, Rx, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-530-01
- Recalling firm
- American Health Packaging
- Quantity
- 19060 blister cards
- Distribution
- Nationwide
- Recall date
- July 24, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)