FDAClass IIIJune 26, 2013

HydrOXYzine Hydrochloride Oral Solution recall: Subpotent

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

Why was HydrOXYzine Hydrochloride Oral Solution recalled?

Subpotent; 24 month stability test station

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Batch 608917 (exp. 02/2014), and Batch 608204 (exp. 01/2014)

Product
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
Recalling firm
Hi-Tech Pharmacal Co., Inc.
Quantity
lot 608917: 7764 bottles; lot 608204: 7476 bottles
Distribution
Nationwide and Puerto Rico
Recall date
June 26, 2013
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls