fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Service...
FDA Recall #D-1047-2023 — Class II — July 17, 2023
Product Description
fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-3
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
1,216 syringes
Distribution
Nationwide in the USA
Code Information
Lot: 17-270771, Exp. 7/19/2023; 17-271134, Exp. 7/25/2023; 17-271577, Exp. 8/1/2023; 17-271745, Exp. 8/3/2023; 17-272026, Exp. 8/9/2023; 17-272345, Exp. 8/15/2023; 17-272615, Exp. 8/20/2023; 17-273668, Exp. 9/6/2023.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated