Reported Nov 5, 2014 · Terminated
HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg / 5mL, Net Wt 16 fl oz (473 mL), NDC 50383-796-16, Rx Only,…
Hi-Tech Pharmacal Co., Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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 / 5mL, Net Wt 16 fl oz (473 mL), NDC 50383-796-16, Rx Only
- Manufactured byHi-Tech Pharmacal Co., Inc. Amityville, NY 11701, ALSO LABELED AS HydrOXYzine HCl Oral Solution, USP, 10 mg / 5 mL, Net Wt 16 fl oz (473 mL), NDC 10702-052-16, Rx Only
- Manufactured forKVK-TECH, INC. NEWTOWN, PA 18940, MADE IN USA
- Manufactured byHi-Tech Pharmacal Co., Inc. Amityville, NY 11701
- Lot codes and dates
- Batch 609442 (exp. 4/2014), 609445 (exp. 4/2014), Batch 609919 (exp. 4/2014), Batch 609964 (exp. 5/2014), Batch 609966 (exp. 5/2014), Batch 610204 (exp. 5/2014), Batch 610406 (exp. 5/2014), Batch 610572 (exp. 6/2014), Batch 610575 (exp. 6/2014), Batch 610677 (exp. 6/2014), Batch 610808 (exp. 6/2014), Batch 611110 (exp. 7/2014), Batch 611201 (exp. 8/2014), Batch 611530 (exp. 8/2014), Batch 611645 (exp.9/2014), Batch 611891 (exp. 9/2014), Batch 611993 (exp. 10/2014), Batch 612328 (exp. 11/2014), Batch 612331 (exp. 11/2014), Batch No. 613050 (exp. 12/2014), Batch 613053 (exp. 12/2014), Batch 613172 (exp. 12/2014), Batch 613175 (exp. 12/2014), Batch 613738 (exp. 1/2015), Batch 613741 (exp. 1/2015), Batch 613744 (exp. 1/2015). Batch 613747 (exp. 1/2015), Batch 613852 (exp. 1/2015), Batch 613855 (exp. 2/2015), Batch 614448 (exp. 2/2015), Batch 614451 (exp. 3/2015), Batch 614914 (exp. 3/2015, Batch 614917 (exp. 3/2015), Batch 615331 (exp. 4/2015), Batch 615334 (exp. 4/2015), Batch 615797 (exp. 5/2015), Batch 615800 (exp. 5/2015), Batch 615947 (exp. 6/2015), Batch 615950 (exp. 6/2015), Batch 616356 (exp. 7/2015), Batch 616359 (exp. 7/2015), Batch 616362 (exp. 7/2015), Batch 616365 (exp. 7/2015), Batch 617066 (exp. 8/2015), Batch 617069 (exp. 8/2015), Batch 617432 (exp. 9/2015), Batch 617435 (exp. 9/2015), Batch 617951 (exp. 10/2015), Batch 617954 (exp. 11/2015), Batch 617957 (exp. 12/2015), Batch 617960 (exp. 12/2015), Batch 618918 (exp. 12/2015), Batch 618920 (exp. 12/2015), Batch 619173 (exp. 1/2016), Batch 619176 (exp. 1/2016), Batch 619543 (exp. 2/2016), Batch 619546 (exp. 2/2016), Batch 620099 (exp. 2/2016), Batch 620102 (exp. 2/2016), Batch 620338 (exp. 2/2016), and Batch 620341 (exp. 2/2016).
- Amount recalled
- 451,916 bottles
Where it was sold
- Nationwide
Why it was recalled
Failed Impurity/Degradation Specification; out-of-specification result for one individual unknown impurity at the 24-month room temperature stability test station.
This product could cause temporary or reversible health problems — stop using it.
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