Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack of Assurance of Sterility
Remicade (Infliximab) injection, 5 mg/kg bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
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 cGMP Deviations: Product intended for quarantine was inadvertently distributed.
Reason Lack of Assurance of Sterility
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