FDA Recalls Fentanyl and Ropivacaine Injectable for Lack of Sterility Assurance
Apollo Care, LLC recalled 308 bags of fentanyl and ropivacaine injectable solution due to lack of assurance of sterility. The affected product was distributed in Missouri only.
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 an FDA Class II drug recall with no reported illnesses or injuries. The hazard—lack of sterility assurance in an injectable medication—represents a risk-of-harm product without reported illness, placing it within the High severity category per the rubric.
Plain-English summary
Apollo Care, LLC is recalling 308 bags of FentaNYL 500 mcg (2mcg/mL) and Ropivacaine HCL 250 mg (0.1%) combined in 250 mL 0.9% Sodium Chloride Injection. The affected lot numbers are AC-016644 (expiration date 05/08/2023) and AC-016659 (expiration date 09/26/2023). The product was distributed in Missouri only.
The recall was initiated because of lack of assurance of sterility. This means the manufacturer cannot confirm that the product meets sterility requirements required for injectable medications.
Healthcare facilities and providers in Missouri that possess this product should discontinue use immediately. Patients who received doses of this medication should contact their healthcare provider.
The recalled product
- Product
- FentaNYL 500 mcg (2mcg/mL) and Ropivacaine HCL 250 mg (0.1%) added to 250 mL 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-950-25
- Manufacturer
- Apollo Care, LLC
- Hazard
- sterility-failure
- contamination-risk
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-016644
- Exp. Date 05/08/2023
- AC-016659
- Exp. Date 09/26/2023
Distribution
Distribution scope not specified by the agency.
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