Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Acetic Acid Otic Solution, 15 mL per bottle, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
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 results obtained for related impurities and slightly lower than the established…
Reason Failed Impurities/Degradation Specifications:Out-of-Specification result for Hydrocortisone related impurity and slightly lower than the established…
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Reason Subpotent Drug: Low Out of specification (OOS) assay results for the hydrocortisone portion of this product.
Reason cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
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