FDAFDA · Food and drugs·Recall number D-1188-2014
HydrOXYzine HCl Tablets, USP 25 mg, 100 Tablet Blister, Rx only Mfd by: KVK-TECH, INC. Newtown, PA 18940, NDC 68084-254-01
Published April 9, 2014 · Recall initiated: January 31, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- American Health Packaging
- Distributor
- Nationwide
- Lot
- Lot 120407, Exp 01/14; Lot 121337 Exp 03/14; Lot 122054, Exp 05/14; Lot 122598, Exp 06/14; Lot 130125, Exp 12/14
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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