HydrOXYzine HCl Tablets, USP 50 mg, 100 Tablet Blister, Rx only Mfd by: KVK-TECH, INC. Newtown, PA 18940, NDC 68084-255-01
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot 120757, Exp. 02/14; Lot 121104, Exp 03/14; Lot 122055, Exp 05/14; Lot 123038, Exp 07/14; Lot 125115, Exp 11/14
- 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:
- Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
HydrOXYzine HCl Tablets, USP 50 mg, 100 Tablet Blister, Rx only Mfd by: KVK-TECH, INC. Newtown, PA 18940, NDC 68084-255-01
Product Codes/Lot Numbers:
Lot 120757, Exp. 02/14; Lot 121104, Exp 03/14; Lot 122055, Exp 05/14; Lot 123038, Exp 07/14; Lot 125115, Exp 11/14
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-1189-2014
Related Recalls
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Subpotent Drug: Out of specification for assay.
Impurity failure at 0-time of the repackaged lot.