fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL syringe, Rx only, Central Admixt...
FDA Recall #D-1062-2023 — Class II — July 17, 2023
Product Description
fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-7
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
2,340 syringes
Distribution
Nationwide in the USA
Code Information
Lot: 17-270813, Exp. 7/19/2023; 17-271485, Exp. 7/31/2023; 17-271809, Exp. 8/6/2023; 17-272314, Exp. 8/14/2023; 17-272780, Exp. 8/22/2023; 17-273141, Exp. 8/29/2023; 17-273687, Exp. 9/6/2023.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated