Class II · Moderate riskCompleted Initiated Jul 2, 2019 (7 years ago)
Perrigo Neomycin and Polymixin B Sulfates and Dexamethasone Ophthalmic Ointment, Net. Wt…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility
What was recalled
Perrigo Neomycin and Polymixin B Sulfates and Dexamethasone Ophthalmic Ointment, Net. Wt 3.5 gm, Sterile, Rx only, Manufactured for Perrigo Minneapolis, MN 55427, NDC 0574-4160-35
Recalling firm
Altaire Pharmaceuticals, Inc.
NDC code
0574-4160-35
Origin
NY, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0352-2020
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…