Reported Mar 21, 2018 · Terminated

Clocortolone Pivalate Cream, 0.1%, 90-gram tube, Rx only, Distributed by: Dr. Reddy's Laboratories, Inc. Princeton, NJ…

Dr. Reddy's Laboratories, 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: Dr. Reddy's Laboratories, Inc. · 107 College Rd E · Princeton, NJ · 08540-6623

Is this the product you have?

  • Clocortolone Pivalate Cream, 0.1%, 90-gram tube, Rx only
  • Distributed byDr. Reddy's Laboratories, Inc. Princeton, NJ 08540
  • Manufactured byDPT, Laboratories Ltd. San Antonio, TX 78215, NDC 43598-341-90
Lot codes and dates
  • Lot # MGEC
Amount recalled
4,152 tubes

Where it was sold

  • Nationwide

Why it was recalled

Failed Stability Specifications:Out-of-specification results observed for viscosity during stability testing.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

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

Read the FDA (openFDA drug enforcement) notice

Notice updated Apr 29, 2019 · Data as of Sep 19, 7:52 PM UTC

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