Recalls / Class II
Class IID-0213-2025
Product
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
- Brand name
- Inflectra
- Generic name
- Infliximab-dyyb
- Active ingredient
- Infliximab
- Route
- Intravenous
- NDC
- 0069-0809
- FDA application
- BLA125544
- Affected lot / code info
- Lot# 04647349, Exp Date 5/31/2029
Why it was recalled
cGMP Deviations: Product intended for quarantine was inadvertently distributed.
Recalling firm
- Firm
- McKesson
- Manufacturer
- Pfizer Laboratories Div Pfizer Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 6555 State Highway 161, Irving, Texas 75039-2402
Distribution
- Quantity
- 192 vials
- Distribution pattern
- Nationwide USA
Timeline
- Recall initiated
- 2025-01-17
- FDA classified
- 2025-01-30
- Posted by FDA
- 2025-02-05
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0213-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.