The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0638-2023·Announced 2023-05-24

Vancomycin Injectable Drug Recalled Due to Lack of Sterility Assurance

Apollo Care, LLC is recalling 1,113 bags of Vancomycin 1.25g injection in 250 mL of 0.9% Sodium Chloride solution due to lack of assurance of sterility. The recall affects product distributed in Missouri.

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 FDA Class II recall of an injectable drug with lack of sterility assurance. No illnesses or hospitalizations have been reported, making this a risk-of-harm scenario with theoretical rather than actual harm, which per the rubric scores at most 3 (High).

Plain-English summary

Apollo Care, LLC is recalling 1,113 bags of Vancomycin 1.25g added to 250 mL of 0.9% Sodium Chloride Injection (NDC 71170-284-25) due to lack of assurance of sterility. The product may not maintain its required sterile condition, which is critical for injectable medications.

The affected lot is AC-016647 with an expiration date of 06/28/2023, distributed in Missouri only.

Healthcare providers and patients should not use this product. Healthcare facilities should remove the affected lot from stock immediately. For questions or to return the product, contact Apollo Care, LLC.

The recalled product

Product
VANComycin 1.25g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-284-25
Manufacturer
Apollo Care, LLC
Category
Drug — Injectable Medication
Hazard
Affected units
1,113

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-016647
  • Exp. Date 06/28/2023

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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