The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0636-2023·Announced 2023-05-24

Vancomycin injection recalled for lack of sterility assurance

Vancomycin 1.5g in 0.9% saline solution being recalled due to lack of assurance of sterility. Product distributed in Missouri with lot numbers AC-016629 and AC-016646.

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 an injectable medication where lack of sterility assurance creates potential for serious infection. As a risk-of-harm product with no reported injuries in the source material, it meets the criteria for High (3) severity.

Plain-English summary

Apollo Care, LLC is recalling VANComycin 1.5g added to 500 mL of 0.9% Sodium Chloride Injection (NDC 71170-185-50). The recall affects 2040 bags distributed in Missouri, with lot numbers AC-016629 (expiration 05/13/2023) and AC-016646 (expiration 06/24/2023).

The product is being recalled due to lack of assurance of sterility. Injectable medications must be sterile to prevent bacterial and other contamination that could cause serious infection in patients receiving treatment.

Healthcare providers and facilities that received affected product should discontinue use immediately and contact Apollo Care, LLC or their pharmacy supplier for instructions on returning or destroying the product. Patients who may have received this medication should speak with their healthcare provider if they have concerns about their treatment.

The recalled product

Product
VANComycin 1.5g added to 500 mL of 0.9% Sodium Chloride Injection, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-185-50
Manufacturer
Apollo Care, LLC
Category
Drug — Injectable / Infusion
Hazard
Affected units
2,040

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 (4)

  • Lot#: AC-016629
  • Exp. Date 05/13/2023
  • AC-016646
  • Exp. Date 06/24/2023

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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