FDA recall record

Apollo Care VANComycin 1g added to 250mL of 0.9% Sodium Chloride recall — FDA D-0277-2022

Crystallization: Product appears to be turbid.

Class IIclassification
D-0277-2022official record ID
Dec 15, 2021report date

Recall record at a glance

Official recordD-0277-2022
CategoryDrug Recalls
ClassificationClass II
FDA record statusTerminated
Recalling firmApollo Care
Report dateDec 15, 2021
Recall initiation dateOct 28, 2021
Quantity225 bags
LocationColumbia, MO, United States

Official 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

Why the product was recalled

Crystallization: Product appears to be turbid.

Distribution information

MO

How to read the classification

FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.

Additional record details

Recall type: Voluntary: Firm initiated. Initial notification: Letter.

What to do next

If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.

About this record

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