Class I — High risk. Reasonable probability of serious harm or death.
Temperature Abuse. 116 cartons with specific serial numbers of Lot 2199821, were stored incorrectly in a controlled room temperature environment instead of the required refrigerated environment.
UDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled Syringe, Rx only, Manufactured by Accord BioPharma, Inc., 8041 Arco Corporate Drive, Suite 200, Raleigh, NC 27617, NDC 69448-025-63
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
Reason Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
Reason Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit
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