The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0645-2023·Announced 2023-05-24

FDA Recall: VANComycin 750mg Injectable Lacks Sterility Assurance

Apollo Care's VANComycin 750mg injectable lacks assurance of sterility. The 491 bags distributed in Missouri are being recalled due to potential contamination risk.

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 FDA Class II recall of an injectable antibiotic addresses lack of sterility assurance rather than confirmed contamination or reported illnesses. The potential for serious infection from non-sterile injectables is significant, but without reported injuries or confirmed contamination details, this ranks as High severity.

Plain-English summary

VANComycin 750mg added to 250 mL of 0.9% Sodium Chloride Injection manufactured by Apollo Care, LLC is being recalled due to lack of assurance of sterility.

The affected product consists of 491 bags with lot number AC-016632 and expiration date 05/24/2023. The product was distributed in Missouri only.

Healthcare providers and patients who have received or are in possession of this product should contact their healthcare provider or pharmacy. Do not use the product if you still have it; return it to your pharmacy or healthcare facility.

The recalled product

Product
VANComycin 750mg added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-255-25
Manufacturer
Apollo Care, LLC
Category
Drug — Injectable / Antibiotic
Hazard
Affected units
491

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-016632
  • Exp. Date 05/24/2023

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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