Diflorasone Diacetate Ointment recall
FDA recall D-0599-2024 · initiated Jun 24, 2024
Rising Pharma Holding, Inc. recalled Diflorasone Diacetate Ointment in Jun 2024 — an FDA Class III recall (D-0599-2024) because Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testing,did not conform to the specification limit.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testing,did not conform to the specification limit.
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 868 tubes
Details
- 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
- Recalling company
- Rising Pharma Holding, Inc.
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Jun 24, 2024
- FDA report date
- Jul 17, 2024
Frequently asked
- Was Diflorasone Diacetate Ointment recalled?
- Rising Pharma Holding, Inc. recalled Diflorasone Diacetate Ointment in Jun 2024 — an FDA Class III recall (D-0599-2024) because Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testing,did not conform to the specification limit. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Diflorasone Diacetate Ointment recalled?
- Per the FDA enforcement record, the reason for recall D-0599-2024 was: Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testing,did not conform to the specification limit.
- Is a recalled Diflorasone Diacetate Ointment dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Diflorasone Diacetate Ointment are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot #, DI2303B, Exp 12/31/2024. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0599-2024.