Recalls / Class II
Class IID-802-2013
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
- Affected lot / code info
- Lot 122600 Exp. 03/14
Why it was 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.
Recalling firm
- Firm
- American Health Packaging
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2550 John Glenn Ave, Suite A, Columbus, Ohio 43217-1188
Distribution
- Quantity
- 19060 blister cards
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2012-10-10
- FDA classified
- 2013-07-15
- Posted by FDA
- 2013-07-24
- Terminated
- 2013-08-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-802-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.