Tobrex 0.3% 3.5gm Opth; Ndc/Upc 65064435; Rx; Ointment
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
What was recalled
TOBREX 0.3% 3.5GM OPTH; NDC/UPC 65064435; RX; OINTMENT
- Recalling firm
- Cardinal Health Inc.
- Origin
- OH, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0533-2021
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.
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