Drug Enforcement D-1080-2023

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
morphine in 0.9% Sodium Chloride, 50 mg/50 mL (1mg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C San Diego, CA 92126, NDC: 71286-2040-4
Product quantity
1,235 syringes
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-1080-2023
Event ID
92752
Recall initiation date
July 17, 2023
Center classification date
August 3, 2023
Code info
Lot: 17-273353, Exp 8/31/2023, 17-270602, Exp 7/17/2023; 17-270706, Exp 7/18/2023; 17-271416, Exp 7/30/2023; 17-272049, Exp 8/9/2023; 17-272277, Exp 8/14/2023; 17-273231, Exp 8/30/2023.
More code info