PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: November 5, 2014 Initiated: April 1, 2014 #D-0048-2015

Product 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.

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.

Details

Units Affected
451,916 bottles
Distribution
nationwide
Location
Amityville, NY

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Hi-Tech Pharmacal Co., Inc.. Units affected: 451,916 bottles.
Why was this product recalled? ▼
Failed Impurity/Degradation Specification; out-of-specification result for one individual unknown impurity at the 24-month room temperature stability test station.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 5, 2014. Severity: Moderate. Recall number: D-0048-2015.

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