Prescription Drug Inflectra Recalled Nationwide for Manufacturing Quality Deviations
McKesson is recalling Inflectra (infliximab-dyyb) injectable drug due to manufacturing quality deviations. A batch intended for quarantine was inadvertently distributed to patients nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for manufacturing quality deviations with no reported illnesses or injuries. This represents a quality-control failure on a distributed drug that was intended for quarantine, fitting the category of risk-of-harm products where injury has not yet been reported.
Plain-English summary
McKesson is recalling Inflectra (infliximab-dyyb) injection, 100mg per vial, due to manufacturing quality deviations. Lot #04647349 with expiration date 5/31/2029 was intended for quarantine but was inadvertently distributed. The recalled product was distributed nationwide, affecting approximately 192 vials.
Inflectra is a TNF blocker injection used to treat inflammatory conditions. The product failed quality control review and was held for quarantine, but was inadvertently distributed in error.
Patients currently taking Inflectra from the affected lot should contact their healthcare provider or pharmacist immediately to determine if their medication is affected. Do not stop taking the medication without consulting your doctor, as abruptly discontinuing this treatment could be harmful. Your healthcare provider can review your specific situation and advise on next steps.
The recalled product
- Product
- INFLECTRA (INFLIXIMAB-DYYB)
- Brand
- INFLECTRA
- Manufacturer
- McKesson
- Category
- Drug — Injectable
- Hazard
- cgmp-violation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot# 04647349
- Exp Date 5/31/2029
UPCs (1)
- 0300690809014
Distribution
Distributed nationwide across the United States.
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