Drug Enforcement D-0637-2023

Lack of Assurance of Sterility

Status

Ongoing

Classification

Class II

Report Date

May 24, 2023

Termination Date

—

Product Information

Product description
Norepinephrine 8 mg added to 250 mL 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-550-25
Product quantity
1617 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-0637-2023
Event ID
92348
Recall initiation date
May 2, 2023
Center classification date
May 18, 2023
Code info
Lot#: AC-016631, Exp. Date 05/29/2023; AC-016655, Exp. Date 08/07/2023
More code info
—