Fentanyl Injectable Syringes Recalled for Lack of Sterility Assurance
Apollo Care's fentanyl 50 mcg/mL injectable syringes are recalled due to lack of assurance of sterility. The 790-syringe batch distributed in Missouri may pose contamination risks if administered.
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 recall of an injectable medication with confirmed sterility assurance failure. While no illnesses have been reported, sterility failures in injectable drugs pose significant risk of microbial contamination, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Apollo Care, LLC is recalling FentaNYL 50 mcg/mL injectable syringes (2,500 mcg total dose per syringe) due to lack of assurance of sterility. The manufacturer cannot confirm that the affected product meets required sterility standards.
The recall affects 790 syringes from lot AC-016624 (expiration date 06/10/2023) distributed in Missouri. This product is a prescription medication used in healthcare settings.
Healthcare providers who received this lot should cease use immediately. Patients who may have received medication from this batch should contact their healthcare provider. Anyone experiencing signs of infection should report symptoms to a healthcare provider without delay.
The recalled product
- Product
- FentaNYL 50 mcg/mL (2,500mcg Total Dose), 50 mL Syringe, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-910-25
- Manufacturer
- Apollo Care, LLC
- Category
- Drug — Injectable / Fentanyl
- Hazard
- sterility-failure
- microbial-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 (2)
- Lot #: AC-016624
- Exp. Date 06/10/2023
Distribution
Distribution scope not specified by the agency.
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