Why it was recalled
cGMP Deviations: Product intended for quarantine was inadvertently distributed.
Product description
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
Lot numbers, UPCs & expiration codes
Lot# 04647349, Exp Date 5/31/2029
Where it was sold
Nationwide USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0213-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jan 17, 2025
- FDA report date
- Feb 5, 2025
- Quantity
- 192 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- McKesson
Original FDA data
Every field from FDA enforcement report D-0213-2025, exactly as published.
Show all FDA fields
- City
- Irving
- State
- TX
- Status
- Ongoing
- Country
- United States
- Event ID
- 96167
- Address
- 6555 State Highway 161
- Code information
- Lot# 04647349, Exp Date 5/31/2029
- Postal code
- 75039-2402
- Report date
- Feb 5, 2025
- Product type
- Drugs
- Recall number
- D-0213-2025
- Classification
- Class II
- Recalling firm
- McKesson
- Product quantity
- 192 vials
- Reason for recall
- cGMP Deviations: Product intended for quarantine was inadvertently distributed.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide USA
- Recall initiation date
- Jan 17, 2025
- Initial firm notification
- Letter
- Center classification date
- Jan 30, 2025