The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0647-2023·Announced 2023-05-24

Vancomycin IV Injection Recalled for Lack of Sterility Assurance

Apollo Care LLC is recalling VANComycin 1.5g IV injections because the manufacturer could not provide adequate assurance that batches met sterility standards. The recall affects 646 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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is a theoretical quality-assurance issue rather than confirmed contamination, making this a precautionary recall.

Plain-English summary

Apollo Care LLC is recalling VANComycin 1.5g added to 250 mL of 0.9% Sodium Chloride Injection (NDC 71170-184-25) due to lack of assurance of sterility.

Sterility assurance is critical for injectable medications. If the manufacturing process cannot guarantee that a product is free of microorganisms, there is a potential risk of infection if the product is administered to patients.

The recall affects 646 bags with the following lot numbers: AC-016633 (Exp. Date 05/24/2023) and AC-016651 (Exp. Date 07/22/2023). These products were distributed in Missouri only.

Healthcare providers and patients should stop using affected lots immediately and consult with their pharmacy or healthcare provider about alternative medications. Do not administer these products. Contact Apollo Care LLC or your pharmacy for product returns.

The recalled product

Product
VANComycin 1.5g added to 250 mL of 0.9% Sodium Chloride Injection, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-184-25
Manufacturer
Apollo Care, LLC
Category
Drug — Injectable
Hazard
Affected units
646

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-016633
  • Exp. Date 05/24/2023
  • AC-016651
  • Exp. Date 07/22/2023

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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