D-1070-2023 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
1,114 bags

Product Description

fentaNYL 2 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride, Total Volume = 100 mL, Total FentaNYL 200 mcg/100 mL, 100 mL bag, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2082-1

Reason for Recall

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

Distribution Pattern

Nationwide in the USA

Code Information

Lot: 17-274485, Exp. 9/19/2023; 17-270783, Exp. 7/19/2023; 17-270882, Exp. 7/20/2023; 17-271430, Exp. 7/30/2023; 17-271509, Exp. 7/31/2023; 17-272224, 17-272238, Exp. 8/13/2023; 17-272704, Exp. 8/21/2023; 17-273147, Exp. 8/29/2023.