Drug Enforcement D-0017-2024

Lack of assurance of sterility:

Status

Terminated

Classification

Class II

Report Date

October 11, 2023

Termination Date

March 19, 2025

Product Information

Product description
fentaNYL 2 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride / Total Volume = 250 mL, Total fentaNYL 500 mcg/250 mL, bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2082-2
Product quantity
190 250 mL bags
Reason for recall
Lack of assurance of sterility:
Recall initiation reason
Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Central Admixture Pharmacy Services Inc
Address
7935 Dunbrook Rd Ste C, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date

Codes & Dates

Recall number
D-0017-2024
Event ID
93103
Recall initiation date
September 21, 2023
Center classification date
October 4, 2023
Code info
Lot: 17-275974, 17-275979, Exp. 10/15/2023; 17-276110, Exp. 10/17/2023; 17-276234, Exp. 10/19/2023.
More code info