FDAFDA · Food and drugs·Recall number D-0599-2024
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
Published July 17, 2024 · Recall initiated: June 24, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testing,did not conform to the specification limit.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- DIFLORASONE DIACETATE
- Manufacturer
- Rising Pharma Holding, Inc.
- Distributor
- Nationwide in the USA
- Lot
- Lot #, DI2303B, Exp 12/31/2024
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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