FDA Drug recall D-0599-2024
Diflorasone Diacetate Ointment, USP, 0.05%, 60g tube, Rx only, Mfd
- FDA Drug
- Class III
- ongoing
- Published 2024-07-17
On 2024-07-17 the FDA classified a Class III recall of Diflorasone Diacetate Ointment, USP, 0.05%, 60g tube, Rx only, Mfd by Rising Pharma Holding, citing failed Impurities/Degradation Specifications: The impurity results at 12 months stability testing,did not conform to the specification limit.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0599-2024 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2024-06-24 |
| Published | 2024-07-17 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Rising Pharma Holding |
| Distribution | US |
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
Reason
Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testing,did not conform to the specification limit.
Identifiers
| ndc | 64980-124-15 |
|---|---|
| ndc | 64980-124-03 |
| ndc | 64980-124-45 |
| ndc | 64980-124-60 |
| code_info | Lot #, DI2303B, Exp 12/31/2024 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
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All Rising Pharma Holding recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0599-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.