Rising Pharma recalls Diflorasone Diacetate ointment for failed impurity specifications
Rising Pharma is recalling 868 tubes of Diflorasone Diacetate ointment because impurity levels failed to meet safety specifications during stability testing. No illnesses have been reported.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class III recall with no reported illnesses or injuries. The hazard is a precautionary quality-control failure—failed impurity specifications—rather than an actual adverse event, consistent with a Moderate-severity classification.
Plain-English summary
Rising Pharma Holding, Inc. is recalling 868 tubes of Diflorasone Diacetate ointment (0.05%, 60g tubes) distributed nationwide. The affected lot is DI2303B with expiration 12/31/2024.
The recall was initiated because impurity testing at 12 months did not conform to specification limits. Diflorasone Diacetate is a topical corticosteroid used to treat skin inflammation. When a medication's impurity levels exceed acceptable standards, the product's safety and quality cannot be guaranteed.
Patients currently using this lot should contact their healthcare provider or pharmacist for guidance. Anyone with this product should stop using it and consult their pharmacy or healthcare provider about obtaining a replacement. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- DIFLORASONE DIACETATE (DIFLORASONE DIACETATE)
- Brand
- DIFLORASONE DIACETATE
- Manufacturer
- Rising Pharma Holding, Inc.
- Category
- Drug — Topical
- Hazard
- Affected units
- 868
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot #
- DI2303B
- Exp 12/31/2024
Distribution
Distributed nationwide across the United States.
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