HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg / 5mL, Net Wt 16 fl oz (473 mL), NDC 50383-796-16, Rx Only, Manufactured by: Hi-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 for: KVK-TECH, INC. NEWTOWN, PA 18940, MADE IN USA, Manufactured by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701.

Class I - Dangerous

💊 Drugs Recalled: April 1, 2014 Hi-Tech Pharmacal Co. Prescription Drugs Nationwide

What Should You Do?

Check if you have this product:
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).
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Hi-Tech Pharmacal Co., Inc.
Reason for Recall:: Failed Impurity/Degradation Specification; out-of-specification result for one individual unknown impurity at the 24-month room temperature stability test station.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg / 5mL, Net Wt 16 fl oz (473 mL), NDC 50383-796-16, Rx Only, Manufactured by: Hi-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 for: KVK-TECH, INC. NEWTOWN, PA 18940, MADE IN USA, Manufactured by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701.

Product Codes/Lot Numbers:

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).