D-1069-2023 Class II Terminated

Recalled by Central Admixture Pharmacy Services Inc — San Diego, CA

Recall Details

Product Type
Drugs
Report Date
August 9, 2023
Initiation Date
July 17, 2023
Termination Date
March 21, 2025
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
295 bags

Product Description

fentaNYL 2 mcg/mL and bupivacaine 0.0625% PF in 0.9% sodium chloride, Total Volume = 250 mL, Total fentaNYL 500 mcg/250 mL, 250 mL bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2081-1

Reason for Recall

Lack of assurance of sterility: Lack of validation data for sanitization cycles

Distribution Pattern

Nationwide in the USA

Code Information

Lot: 17-271814, Exp. 8/6/2023; 17-271960, Exp. 8/8/2023; 17-272252, Exp. 8/13/2023; 17-272272, Exp. 8/14/2023; 17-272454, Exp. 8/16/2023; 17-272640, Exp. 8/20/2023; 17-272716, Exp. 8/21/2023.