Reported Jun 26, 2013 · Terminated
HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 16 fl. oz. (473 mL), Rx Only, HI-TECH PHARMACAL CO., INC.…
Hi-Tech Pharmacal Co., Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hi-Tech Pharmacal Co., Inc. · 369 Bayview Ave · Amityville, NY · 11701-2801
Is this the product you have?
- 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
- Lot codes and dates
Batch 608917 (exp. 02/2014)and Batch 608204 (exp. 01/2014)
- Amount recalled
- lot 608917: 7764 bottles; lot 608204: 7476 bottles
Where it was sold
- Nationwide
- PR
Why it was recalled
Subpotent; 24 month stability test station
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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