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Drug FDA Class III Ongoing Failed specifications

Diflorasone Diacetate Ointment, USP, 0.05%, 60g tube, Rx only, Mfd. By: Lyne Laboratories, Inc., Brockton, MA 02301; Mfd. For: Rising Pharmaceuticals, Inc., East Brunswick, NJ 08816 NDC 64980-124-60

Rising Pharma Holding, Inc. Published Jul 17, 2024

Risk level

Class III

Unlikely to cause harm, but violates labeling or manufacturing rules.

Severity score 40/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Rising Pharma Holding, Inc. or your place of purchase with questions, and see the source record below for full details.
Reason for recall

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

Hazards

Failed Impurities/Degradation Specifications · primary

Affected products (1)

Diflorasone Diacetate Ointment, USP, 0.05%, 60g tube, Rx only, Mfd. By: Lyne Laboratories, Inc., Brockton, MA 02301; Mfd. For: Rising Pharmaceuticals, Inc., East Brunswick, NJ 08816 NDC 64980-124-60

DIFLORASONE DIACETATE · 868 tubes

NDC: 64980-124, 64980-124-15, 64980-124-03, 64980-124-45, 64980-124-60
Code info: Lot #, DI2303B, Exp 12/31/2024

Affected areas

Nationwide

Timeline

  1. Initiated
    Jun 24, 2024
  2. Published
    Jul 17, 2024
Recall number
D-0599-2024
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.