Drug Enforcement D-0647-2023

Lack of Assurance of Sterility

Status

Ongoing

Classification

Class II

Report Date

May 24, 2023

Termination Date

Product Information

Product description
VANComycin 1.5g added to 250 mL of 0.9% Sodium Chloride Injection, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-184-25
Product quantity
646 bags
Reason for recall
Lack of Assurance of Sterility
Recall initiation reason
Initial firm notification
Letter
Distribution pattern
Missouri only

Location & Firm

Recalling firm
Apollo Care, LLC
Address
3801 Mojave Ct Ste 101, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date

Codes & Dates

Recall number
D-0647-2023
Event ID
92348
Recall initiation date
May 2, 2023
Center classification date
May 18, 2023
Code info
Lot #: AC-016633, Exp. Date 05/24/2023; AC-016651, Exp. Date 07/22/2023
More code info