Drug Enforcement D-1069-2023

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

Status

Terminated

Classification

Class II

Report Date

August 9, 2023

Termination Date

March 21, 2025

Product Information

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
Product quantity
295 bags
Reason for recall
Lack of assurance of sterility: Lack of validation data for sanitization cycles
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-1069-2023
Event ID
92752
Recall initiation date
July 17, 2023
Center classification date
August 3, 2023
Code info
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.
More code info