Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Failed Impurities/Degradation Specifications: Expansion of October 2018 recall due to elevated out of specification results for total impurities that have been chemically identified as oxidative degradation products of the fluocinolone active pharmaceutical ingredient.
Fluocinolone Acetonide Topical Solution, USP, 0.01 %, 60 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202; Manufactured by: Novel Laboratories, Inc., Somerset, NJ 08873; NDC 43386-069-60.
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
Reason Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol
Reason Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper.
Reason Lack of Processing Controls (lack of assurance of conformity to specifications).
Reason Lack of Processing Controls (lack of assurance of conformity to specifications).
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