D-0213-2025 Class II Ongoing
FDA drug recall D-0213-2025 was initiated by McKesson on January 17, 2025 and is designated Class II. Reason for recall: cGMP Deviations: Product intended for quarantine was inadvertently distributed. The recall status is ongoing. Affected quantity: 192 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- February 5, 2025
- Initiation Date
- January 17, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 192 vials
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
Reason for Recall
cGMP Deviations: Product intended for quarantine was inadvertently distributed.
Distribution Pattern
Nationwide USA
Code Information
Lot# 04647349, Exp Date 5/31/2029