The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0634-2023·Announced 2023-05-24

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.

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 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
Affected units
790

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

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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