Class II · Moderate riskTerminated Initiated Apr 22, 2013 (13 years ago)
Dexamethasone Opth Soln 0.1% PF, 10 ml Opthalmic Soln, 30 day expiration,
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
What was recalled
Dexamethasone Opth Soln 0.1% PF, 10 ml Opthalmic Soln, 30 day expiration,
Recalling firm
Nora Apothecary and Alternative Therapies, Inc.
Origin
IN, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-473-2013
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 - OOS impurities result observed during long term stability testing at product expiry (24 months) were…