Class II · Moderate risk
Clobetasol Propionate Foam
CGMP Deviations
Flunisolide Nasal Solution
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Out of specification for related substances (impurities).
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
Flunisolide Nasal Solution, USP 0.025%, 25 mL bottles, Rx only, Manufactured for: Ingenus Pharmaceuticals, LLC Orlando, FL 32839-6408; NDC 50742-317-25 UPC 3 50742 31725 7
Affected NDC
50742-0317-25
Compare with the code on your package — it is the most precise check available.
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Flunisolide NDC 50742-0317 |
.25 mg/mL | Solution Nasal |
Ingenus Pharmaceuticals, LLC | Rx |
- Recalling firm
- Ingenus Pharmaceuticals Llc
- NDC code
- 50742-317-25
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0010-2023 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now completed, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Ingenus Pharmaceuticals Llc
All 2022 recalls
Class II · Moderate risk
Leucovorin Calcium Injection
Crystallization: Presence of particulate matter identified as API crystallization
Class III · Low risk
Diclofenac Sodium Topical Solution
Defective Container: firm discovered samples stored horizontally as well as product quality complaints from customers for bottles leaking.
Class II · Moderate risk
Irinotecan Hydrochloride Injection
Superpotent Drug: High out of specification assay value results for potency.
Other impurity / degradation recalls from 2022
All impurity / degradation recalls
Class II · Moderate risk
BuPROPion Hydrochloride Tablets
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Glycopyrrolate Tablets
Failed impurities/degradation specifications: Out of specification for unknown impurities.
Class II · Moderate risk
Rifampin Capsules USP
Failed Impurities/Degradations Specifications
Class II · Moderate risk
Rifampin Capsules
Failed Impurities/Degradation specifications
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