FDA recall record

Apollo Care Vancomycin 1.25g added to 250mL of 0.9% Sodium Chloride IV bag recall — FDA D-0580-2018

Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is not supported.

Class IIclassification
D-0580-2018official record ID
Mar 14, 2018report date

Recall record at a glance

Official recordD-0580-2018
CategoryDrug Recalls
ClassificationClass II
FDA record statusTerminated
Recalling firmApollo Care
Report dateMar 14, 2018
Recall initiation dateFeb 15, 2018
Quantity312 bags
LocationColumbia, MO, United States

Official product description

Vancomycin 1.25g added to 250mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOcare, 3801 Mojave Ct., Suite 101, Columbia, MO 65202, NDC 71170-264-25.

Why the product was recalled

Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is not supported.

Distribution information

Medical Facility in 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: E-Mail.

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

Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.

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