Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Failed Impurities and Degradation Specifications and Subpotent Drug: out-of-specification (OOS) test results for below assay and above specification for degradants.
Fluocinolone Acetonide Topical Solution, USP, 0.01%, 60 mL bottle, Rx Only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, UT 84108 USA; Distributed by: Actavis Pharmac, Inc., Parsippany, NJ 07054 USA, NDC 0591-2990-60.
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).
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.