Drug Enforcement D-0636-2023

Lack of Assurance of Sterility

Status

Ongoing

Classification

Class II

Report Date

May 24, 2023

Termination Date

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Product Information

Product description
VANComycin 1.5g added to 500 mL of 0.9% Sodium Chloride Injection, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-185-50
Product quantity
2040 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-0636-2023
Event ID
92348
Recall initiation date
May 2, 2023
Center classification date
May 18, 2023
Code info
Lot#: AC-016629, Exp. Date 05/13/2023; AC-016646, Exp. Date 06/24/2023
More code info
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