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.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Hi-Tech Pharmacal Co., Inc. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated May 13, 2016 · Data as of Sep 19, 6:35 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.