FDA Recall D-0213-2025
McKesson · Irving, TX
Class II Ongoing 482 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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
Reason for recall
cGMP Deviations: Product intended for quarantine was inadvertently distributed.
Recall record
- Recall number
D-0213-2025- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide USA
- Recall initiated
- 2025-01-17
- Classified by FDA Center
- 2025-01-30
- FDA published
- 2025-02-05
- Recalling firm
- McKesson
- Firm location
- Irving, TX
Drug identification
- Brand name(s)
- INFLECTRA
- Generic name(s)
- INFLIXIMAB-DYYB
- Manufacturer(s)
- Pfizer Laboratories Div Pfizer Inc
- NDC(s)
0069-0809- Route(s)
- INTRAVENOUS
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.