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.
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
Lot numbers, UPCs & expiration codes
Lot 122600 Exp. 03/14
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-802-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 10, 2012
- FDA report date
- Jul 24, 2013
- Quantity
- 19060 blister cards
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- American Health Packaging
Original FDA data
Every field from FDA enforcement report D-802-2013, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 65683
- Address
- 2550 John Glenn Ave
- Address (line 2)
- Suite A
- Code information
- Lot 122600 Exp. 03/14
- Postal code
- 43217-1188
- Report date
- Jul 24, 2013
- Product type
- Drugs
- Recall number
- D-802-2013
- Classification
- Class II
- Recalling firm
- American Health Packaging
- Product quantity
- 19060 blister cards
- Termination date
- Aug 21, 2013
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Oct 10, 2012
- Initial firm notification
- Letter
- Center classification date
- Jul 15, 2013