NDC 64980-124
Diflorasone Diacetate 0.5 mg per 1 g ointment
On the label: Rising Pharma Holdings, Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Lyne Laboratories, Inc. | Brockton, MA, United States | Makes it | Problems found, fixed voluntarilyMar 10, 2026 · 9 inspections, 1 with FDA action |
Recalls
- Jun 24, 2024 · Class III · Rising Pharma Holding, Inc.
Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testing,did not conform to the specification limit.
Lots: Lot #, DI2303B, Exp 12/31/2024
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Diflorasone: every company that makes it
- Form
- ointment, topical
- Strength
- 0.5 mg per 1 g
- Approval
- ANDA ANDA207440
- On the market since
- Feb 27, 2017
- Package NDCs
64980-124-0364980-124-1564980-124-4564980-124-60- Official label
- DailyMed (National Library of Medicine), updated May 2, 2023
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