Recalls / Class III
Class IIID-0599-2024
Product
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
- Brand name
- Diflorasone Diacetate
- Generic name
- Diflorasone Diacetate
- Active ingredient
- Diflorasone Diacetate
- Route
- Topical
- NDC
- 64980-124
- FDA application
- ANDA207440
- Affected lot / code info
- Lot #, DI2303B, Exp 12/31/2024
Why it was recalled
Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testing,did not conform to the specification limit.
Recalling firm
- Firm
- Rising Pharma Holding, Inc.
- Manufacturer
- Rising Pharma Holdings, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2 Tower Center Blvd Ste 1401, N/A, East Brunswick, New Jersey 08816-1149
Distribution
- Quantity
- 868 tubes
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2024-06-24
- FDA classified
- 2024-07-16
- Posted by FDA
- 2024-07-17
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0599-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.