Inflectra recall: CGMP Deviations
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
Why was Inflectra recalled?
cGMP Deviations: Product intended for quarantine was inadvertently distributed.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot# 04647349, Exp Date 5/31/2029
- 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
- Recalling firm
- McKesson
- Quantity
- 192 vials
- Distribution
- Nationwide USA
- Recall date
- February 5, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)