The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0635-2023·Announced 2023-05-24

Apollo Care Ketamine Injection Recalled Due to Sterility Assurance Defect

Apollo Care is recalling Ketamine Injection single-use syringes (2,040 units) distributed in Missouri due to lack of assurance of sterility. Patients should consult their healthcare provider if affected.

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 Class II recall with no reported illnesses or injuries. A sterility failure in an injectable drug represents a risk-of-harm product where injury has not yet been reported, meriting a High (3) severity score per the rubric.

Plain-English summary

Apollo Care, LLC is recalling Ketamine Injection, 50 mg per 5 mL (10 mg/mL), in single-use syringes (NDC 71170-050-05) due to lack of assurance of sterility. The recall affects 2,040 syringes that were distributed in Missouri.

The affected lots are AC-016627 (Exp. 06/17/2023), AC-016635 (Exp. 07/08/2023), and AC-016662 (Exp. 09/30/2023). For injectable products, sterility is critical to prevent microbial contamination and ensure patient safety.

Healthcare providers and patients with affected syringes should consult their healthcare provider. For additional information, contact Apollo Care, LLC at 3801 Mojave Ct., Suite 101, Columbia, MO 65202.

The recalled product

Product
Ketamine Injection, 50 mg per 5 mL (10 mg/mL), Single-Use Syringe, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-050-05
Manufacturer
Apollo Care, LLC
Category
Drug — Injectable / Ketamine
Hazard
Affected units
2,040

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 (6)

  • Lot #: AC-016627
  • Exp. Date 06/17/2023
  • AC-016635
  • Exp. Date 07/08/2023
  • AC-016662
  • Exp. Date 09/30/2023

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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