The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0640-2023·Announced 2023-05-24

Vancomycin Injectable Drug Recalled Due to Lack of Sterility Assurance

Apollo Care, LLC is recalling VANComycin 1 g added to 250 mL of 0.9% Sodium Chloride Injection due to lack of assurance of sterility. The recall affects 1,622 bags 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 product with a potential sterility issue. No reported illnesses or injuries are mentioned in the source, placing this at the High level per the rubric criterion of risk-of-harm products where injury has not yet been reported.

Plain-English summary

Apollo Care, LLC is recalling VANComycin 1 g added to 250 mL of 0.9% Sodium Chloride Injection, NDC 71170-254-25. The recall was issued due to a lack of assurance of sterility in the product.

The affected product includes 1,622 bags with the following lot numbers and expiration dates: Lot AC-016641 (Exp. 06/03/2023) and Lot AC-016653 (Exp. 07/26/2023). Distribution was limited to Missouri.

Healthcare providers and patients who have this product should discontinue use and contact Apollo Care, LLC at 3801 Mojave Ct., Suite 101, Columbia, MO 65202 for instructions on how to return the product. Patients should consult with their healthcare provider regarding appropriate alternative treatment.

The recalled product

Product
VANComycin 1 g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-254-25
Manufacturer
Apollo Care, LLC
Category
Drug
Hazard
Affected units
1,622

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 (3)

  • Lot #: AC-016641
  • Exp. Date 06/03/2023
  • AC-016653 Exp. Date 07/26/2023

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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