The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0637-2023·Announced 2023-05-24

FDA Recalls Apollo Care Norepinephrine Injections Due to Sterility Assurance Failure

Apollo Care, LLC is recalling 1,617 bags of Norepinephrine 8 mg intravenous injection distributed in Missouri due to lack of assurance that the product meets sterility requirements.

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 a risk-of-harm product (injectable medication) where sterility is a critical safety requirement. The FDA classified it as Class II. No illnesses or injuries are reported in the source text; therefore, per the rubric, the score does not exceed 3.

Plain-English summary

Apollo Care, LLC is recalling 1,617 bags of Norepinephrine 8 mg added to 250 mL 0.9% Sodium Chloride Injection (NDC 71170-550-25) distributed in Missouri only.

The recall was issued because the manufacturer cannot assure that the product meets sterility requirements. Norepinephrine is a critical injectable medication administered in clinical settings; sterility is a required safety standard for all intravenous products.

The affected lots are AC-016631 (expiration date 05/29/2023) and AC-016655 (expiration date 08/07/2023). Healthcare facilities and providers in Missouri who received this product should verify their inventory against these lot numbers and contact Apollo Care, LLC for instructions on handling or replacement of affected stock.

The recalled product

Product
Norepinephrine 8 mg added to 250 mL 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-550-25
Manufacturer
Apollo Care, LLC
Category
Drug — Injectable Medication
Hazard
Affected units
1,617

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-016631
  • Exp. Date 05/29/2023
  • AC-016655
  • Exp. Date 08/07/2023

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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