The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0642-2023·Announced 2023-05-24

Vancomycin Injectable Solution Recalled Due to Lack of Sterility Assurance

Apollo Care, LLC is recalling 413 bags of Vancomycin 2g injectable solution (Lot #AC-016638, expiration 05/27/2023) distributed in Missouri due to lack of assurance of sterility.

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 drug recall for an injectable medication due to lack of sterility assurance. While the source does not report any illnesses or hospitalizations, non-sterile injectables present a significant risk of infection and contamination. This ranks as High severity per the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Apollo Care, LLC is recalling Vancomycin 2g added to 500 mL of 0.9% Sodium Chloride Injection (NDC 71170-204-50). The affected lot is AC-016638 with an expiration date of 05/27/2023. The product was distributed in Missouri. A total of 413 bags have been recalled.

The recall was initiated due to a lack of assurance of sterility. Injectable medications that are not sterile can pose serious health risks to patients.

Patients who received this product should contact their healthcare provider. Healthcare providers should discontinue use of this product and contact the manufacturer regarding return procedures.

The recalled product

Product
VANComycin 2g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only. Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-204-50
Manufacturer
Apollo Care, LLC
Category
Drug — Injectable
Hazard
Affected units
413

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-016638
  • Exp. Date 05/27/2023

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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