Reported Jul 17, 2024 · Ongoing

Diflorasone Diacetate Ointment, USP, 0.05%, 60g tube, Rx only, Mfd. By: Lyne Laboratories, Inc., Brockton, MA 02301;…

Rising Pharma Holding, 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: Rising Pharma Holding, Inc. · 2 Tower Center Blvd Ste 1401 · East Brunswick, NJ · 08816-1149

Is this the product you have?

  • Diflorasone Diacetate Ointment, USP, 0.05%, 60g tube, Rx only, Mfd
  • ByLyne Laboratories, Inc., Brockton, MA 02301; Mfd
  • ForRising Pharmaceuticals, Inc., East Brunswick, NJ 08816 NDC 64980-124-60
Lot codes and dates
    • Lot #
    • DI2303B
    • Exp 12/31/2024
Amount recalled
868 tubes

Where it was sold

  • Nationwide

Why it was recalled

Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testing,did not conform to the specification limit.

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 Rising Pharma Holding, 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

Data as of Sep 19, 4:18 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.