The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0643-2023·Announced 2023-05-24

VANComycin Injectable Recalled for Lack of Sterility Assurance

Apollo Care, LLC is recalling a VANComycin injectable medication due to lack of assurance of sterility. The affected lot was distributed in Missouri only.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II recall of an injectable medication with lack of sterility assurance. While no illnesses have been reported, the product represents a risk-of-harm situation where a compromise in sterility directly threatens patient safety, meeting the rubric criterion for High severity.

Plain-English summary

Apollo Care, LLC is recalling 54 bags of VANComycin 2.5 g added to 500 mL of 0.9% Sodium Chloride Injection due to lack of assurance of sterility. The affected product was distributed in Missouri only.

The recalled lot is identified as AC-016649 with an expiration date of 07/01/2023. Because the sterility of this injectable medication cannot be assured, patients who received this product should contact their healthcare provider to discuss any concerns.

Non-sterile injectables can pose a risk of serious infection. Healthcare providers should verify whether any patients they are treating may have received this product from the affected lot.

The recalled product

Product
VANComycin 2.5 g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-224-50
Manufacturer
Apollo Care, LLC
Category
Drug — Injectable
Hazard
Affected units
54

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot #: AC-016649
  • Exp. Date 07/01/2023

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 16 recalled by Apollo Care, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 16 products in this recall →

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