QUETIAPINE Fumarate Tablets 25mg 100 Tablets (10x10) Blister card, Rx, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-530-01
Reported: July 24, 2013 Initiated: October 10, 2012 #D-802-2013
Product Description
QUETIAPINE Fumarate Tablets 25mg 100 Tablets (10x10) Blister card, Rx, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-530-01
Reason for Recall
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.
Details
- Recalling Firm
- American Health Packaging
- Units Affected
- 19060 blister cards
- Distribution
- Nationwide
- Location
- Columbus, OH
Frequently Asked Questions
What product was recalled? ▼
QUETIAPINE Fumarate Tablets 25mg 100 Tablets (10x10) Blister card, Rx, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-530-01. Recalled by American Health Packaging. Units affected: 19060 blister cards.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 24, 2013. Severity: Moderate. Recall number: D-802-2013.
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