FDA Drugs recall ·
Inflectra (infliximab-dyyb), For injection, 100mg per vial… recall
- Recall number
- D-0213-2025
- Date
- (initiated January 17, 2025)
- Company / brand
- McKesson
6555 State Highway 161, Irving, TX, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 192 vials
- Hazard tags
- Manufacturing practices (cGMP)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
cGMP Deviations: Product intended for quarantine was inadvertently distributed.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot# 04647349, Exp Date 5/31/2029
Distribution
Nationwide USA
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0213-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.