Inflectra (infliximab-dyyb), For injection, 100mg per vial, packaged in 10 mL single-dose vial, Rx only, Mfd by: CELLTRI
Summary
The FDA issued a Class II for Inflectra (infliximab-dyyb), For injection, 100mg per vial, packaged in 10 mL si by McKesson. Reason: cGMP Deviations: Product intended for quarantine was inadvertently distributed..
Details
Source
Drug Recall
External ID
D-0213-2025
Action Date
2025-02-05
Status
Ongoing
Category
drug
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/Code Info: Lot# 04647349, Exp Date 5/31/2029
Quantity Affected: 192 vials
Reason for Recall
cGMP Deviations: Product intended for quarantine was inadvertently distributed.
Distribution
Nationwide USA
Type: Voluntary: Firm initiated
Recall Initiated: 2025-01-17
Company
Irving, TX
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 45 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
McKesson has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (McKesson) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does McKesson have FDA actions?
McKesson has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0213-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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