Drug 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
D-0213-2025
Product summary
- Firm
- McKesson
- Event
- Event 96167
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 192 vials
- Official record key
drug-enforcement:D-0213-2025
Official wording
Reason: cGMP Deviations: Product intended for quarantine was inadvertently distributed.
Code information: Lot# 04647349, Exp Date 5/31/2029
Distribution pattern: Nationwide USA
Derived failure modes
-
Manufacturing or process control
cGMP Deviations