The Recall Desk
HighFDA (Drugs)·D-0020-2024·Announced 2023-10-11

Fentanyl Injectable Syringes Recalled Due to Sterility Assurance Issues

Central Admixture Pharmacy Services recalled 174 fentanyl syringes nationwide due to lack of sterility assurance. The affected injectable medication presents a contamination risk.

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: FDA Class II drug recall involving a sterility assurance failure on an injectable medication. While no illnesses or hospitalizations are reported, this represents a significant risk-of-harm product where potential injury has not yet been documented.

Plain-English summary

Central Admixture Pharmacy Services Inc is recalling fentanyl 250 mcg/5 mL (50 mcg/mL) injectable syringes due to lack of assurance of sterility. A total of 174 five-milliliter syringes have been affected.

The recalled product failed to meet sterility standards. Fentanyl that is not adequately sterilized or confirmed to be sterile presents a contamination risk to patients receiving the medication.

The affected fentanyl was distributed nationwide. The recall involves two lot numbers: 17-275479 (Exp. 10/4/2023) and 17-275852 (Exp. 10/11/2023), repackaged by Central Admixture Pharmacy Services Inc in San Diego, California.

Patients and healthcare providers should stop using this product immediately. Contact Central Admixture Pharmacy Services Inc for instructions on product return and replacement. If you received an injection from one of these lots, contact your healthcare provider.

The recalled product

Product
fentaNYL, 250 mcg/5 mL, (50 mcg/mL), 5 mL Syringe, Rx only, Repackaged by CAPS Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-2
Manufacturer
Central Admixture Pharmacy Services Inc
Hazard
  • contamination-risk
  • sterility-failure

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:17-275479
  • Exp. 10/4/2023
  • 17-275852
  • Exp. 10/11/2023

Distribution

Distributed nationwide across the United States.