Reported Aug 21, 2013 · Terminated

Clobetasol Propionate Cream, USP, 0.05%, 15 grams, Rx only, Hi-Tech PHARMACAL label, 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?

  • Clobetasol Propionate Cream, USP, 0.05%, 15 grams, Rx only, Hi-Tech PHARMACAL label, Hi-Tech Pharmacal, Co., Inc., Amityville, NY 11701, NDC 50383-267-15 --- For dermatologic use only. Product is packaged into tubes and then placed into unit cartons.
Lot codes and dates
    • Batch/Lot 619442
    • exp. 01/2015
Amount recalled
58,812 tubes

Where it was sold

  • Nationwide
  • PR

Why it was recalled

Labeling: Label Mix-up; some cartons labeled as Clobetasol Propionate Cream USP contain tubes labeled as Clobetasol Propionate Gel USP. The actual product in the tube is Clobetasol Propionate Cream USP

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 16, 2016 · Data as of Sep 19, 5:03 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.