Status
Terminated
Drug Enforcement D-802-2013
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.
Classification
Class II
Report Date
July 24, 2013
Termination Date
August 21, 2013
Product Information
- 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
- Product quantity
- 19060 blister cards
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- American Health Packaging
- Address
-
2550 John Glenn Ave, Suite A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-802-2013
- Event ID
- 65683
- Recall initiation date
- October 10, 2012
- Center classification date
- July 15, 2013
- Code info
- Lot 122600 Exp. 03/14
- More code info
- —