Class II · Moderate risk Terminated
InFLIXimab 300 mg / 250 ml 0.9% NACL IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Reason Lack of Assurance of Sterility
Inflectra (infliximab-dyyb), For injection, 100mg per vial, packaged in 10 mL single-dose…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
cGMP Deviations: Product intended for quarantine was inadvertently distributed.
What was recalled
Inflectra (infliximab-dyyb), For injection, 100mg per vial, packaged in 10 mL single-dose vial, Rx only, Mfd by: CELLTRION, INC, Dist. by: Pfizer Labs, Division of Pfizer Inc., New York, NY 10001, NDC 0069-0809-01
- Recalling firm
- McKesson
- NDC code
- 0069-0809-01
- Origin
- TX, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0213-2025
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.
Other Infliximab recalls
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Class II · Moderate risk Terminated
Remicade (Infliximab) injection, 5 mg/kg bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Reason Lack of Assurance of Sterility
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