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
Reported: June 26, 2013 Initiated: April 30, 2013 #D-603-2013
Product Description
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
Reason for Recall
Subpotent; 24 month stability test station
Details
- Recalling Firm
- Hi-Tech Pharmacal Co., Inc.
- Units Affected
- lot 608917: 7764 bottles; lot 608204: 7476 bottles
- Distribution
- Nationwide and Puerto Rico
- Location
- Amityville, NY
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Hi-Tech Pharmacal Co., Inc.. Units affected: lot 608917: 7764 bottles; lot 608204: 7476 bottles.
Why was this product recalled? ▼
Subpotent; 24 month stability test station
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 26, 2013. Severity: Low. Recall number: D-603-2013.
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