VANComycin 750mg added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 10
Summary
The FDA issued a Class II for VANComycin 750mg added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apo by Apollo Care, LLC. Reason: Lack of Assurance of Sterility.
Details
Source
Drug Recall
External ID
D-0645-2023
Action Date
2023-05-24
Status
Ongoing
Category
drug
Product Description
VANComycin 750mg added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-255-25
Lot/Code Info: Lot #: AC-016632, Exp. Date 05/24/2023
Quantity Affected: 491 bags
Reason for Recall
Lack of Assurance of Sterility
Distribution
Missouri only
Type: Voluntary: Firm initiated
Recall Initiated: 2023-05-02
Company
Columbia, MO
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 99 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Apollo Care, LLC has 17 FDA actions in our database, including 17 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Apollo Care, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Apollo Care, LLC have FDA actions?
Apollo Care, LLC has 17 FDA actions in our database, including 17 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0645-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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