fentaNYL in 0.9% sodium chloride, 100 mcg/10 mL, (10 mcg/mL), 10 mL Syringe, Rx only, Central Adm...
FDA Recall #D-1053-2023 — Class II — July 17, 2023
Product Description
fentaNYL in 0.9% sodium chloride, 100 mcg/10 mL, (10 mcg/mL), 10 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2071-2
Reason for Recall
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Recalling Firm
Central Admixture Pharmacy Services Inc — San Diego, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
1669 syringes
Distribution
Nationwide in the USA
Code Information
Lot: 17-270685, Exp. 7/18/2023; 17-271343, Exp. 7/27/2023; 17-271490, Exp. 7/31/2023; 17-271578, Exp. 8/1/2023; 17-272293, Exp. 8/14/2023; 17-272786, Exp. 8/22/2023; 17-273575, Exp. 9/5/2023.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated