VANComycin 1g added to 250mL of 0.9% Sodium Chloride (Injection for Intravenous Use Only), 260 mL per bag, Rx Only, This
Summary
The FDA issued a Class II for VANComycin 1g added to 250mL of 0.9% Sodium Chloride (Injection for Intravenous by Apollo Care. Reason: Crystallization: Product appears to be turbid..
Details
Source
Drug Recall
External ID
D-0277-2022
Action Date
2021-12-15
Status
Terminated
Category
drug
Product Description
VANComycin 1g added to 250mL of 0.9% Sodium Chloride (Injection for Intravenous Use Only), 260 mL per bag, Rx Only, This is a Compounded Drug, Hospital/Office Use Only, Apollo Care 3801 Mojave Ct, Suite 101, Columbia, MO 65202, NDC 71170-254-25
Lot/Code Info: Lot #: AC-016402, Exp 2/12/2022
Quantity Affected: 225 bags
Reason for Recall
Crystallization: Product appears to be turbid.
Distribution
MO
Type: Voluntary: Firm initiated
Recall Initiated: 2021-10-28
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 28 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Apollo Care has 2 FDA actions in our database, including 2 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) 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 have FDA actions?
Apollo Care has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0277-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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