QUETIAPINE Fumarate Tablets 25mg 100 Tablets (10x10) Blister card, Rx, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-530-01
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot 122600 Exp. 03/14
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- American Health Packaging
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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 Codes/Lot Numbers:
Lot 122600 Exp. 03/14
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-802-2013
Related Recalls
Failed Dissolution Specifications: Nitrofurantoin Capsules recalled due to dissolution failure at 0-time of the repackaged lot. Drug release results were above specification at 0-time.
Subpotent Drug: Out of specification for assay.
Impurity failure at 0-time of the repackaged lot.