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.
What this means for you
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
- sterility
- contamination
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
Distribution scope not specified by the agency.
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