The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0639-2023·Announced 2023-05-24

Injectable Vancomycin Recalled Due to Lack of Sterility Assurance

Apollo Care LLC is recalling 1,113 bags of VANComycin injectable solution due to lack of assurance of sterility. The recalled product was 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 a sterile injectable product with no reported illnesses or injuries. The hazard—lack of sterility assurance—represents a risk of harm to patients, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Apollo Care LLC is recalling VANComycin 1.25 grams in 250 mL bags of 0.9% Sodium Chloride Injection (NDC 71170-264-25) due to lack of assurance of sterility. A total of 1,113 bags from Lot AC-016647 with an expiration date of June 28, 2023, have been recalled.

Sterility is a critical requirement for injectable pharmaceuticals. The manufacturer was unable to provide adequate assurance that all units maintained sterile conditions during manufacture, storage, and distribution.

The recalled product was distributed in Missouri only. Healthcare providers and patients who have received this product should consult with their healthcare provider regarding any health concerns. Persons with unused product should contact Apollo Care LLC at their Columbia, Missouri facility.

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 71170-264-25
Manufacturer
Apollo Care, LLC
Category
Drug — Sterile Injectable Preparation
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 →

Related recalls

Same manufacturer · Apollo Care, LLC

See all →

Same hazard · sterility

See all →

Similar recalls