Drug Enforcement D-1076-2023

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
rocuronium, 50 mg /5 mL, (10 mg/mL), 5 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6010-1
Product quantity
10,065 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-1076-2023
Event ID
92752
Recall initiation date
July 17, 2023
Center classification date
August 3, 2023
Code info
Lot: 17-270519, Exp. 7/16/2023; 17-270605, Exp. 7/17/2023; 17-270684, Exp. 7/18/2023; 17-270898, Exp. 7/20/2023; 17-271074, Exp. 7/24/2023; 17-271324, Exp. 7/27/2023; 17-271603, Exp. 8/1/2023; 17-271670, Exp. 8/2/2023; 17-272529, Exp. 8/17/2023; 17-272883, Exp. 8/23/2023; 17-273235, 17-273245, 17-273262, 17-273263, 17-273264, Exp. 8/30/2023; 17-273418, Exp. 9/3/2023; 17-273768, 17-273788, Exp. 9/7/2023; 17-274022, Exp. 9/12/2023.
More code info