FDAFDA · Food and drugs·Recall number D-603-2013
HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 16 fl. oz. (473 mL), Rx Only, HI-TECH PHARMACAL CO., INC. AMITYVILLE, NY, NDC 50383-796-16
Published June 26, 2013 · Recall initiated: April 30, 2013
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
Subpotent; 24 month stability test station
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Hi-Tech Pharmacal Co., Inc.
- Distributor
- Nationwide and Puerto Rico
- Lot
- Batch 608917 (exp. 02/2014), and Batch 608204 (exp. 01/2014)
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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