The Recall Desk
HighFDA (Drugs)·D-0001-2024·Announced 2023-10-11

Fentanyl Injectable Syringes Recalled for Lack of Sterility Assurance

Central Admixture Pharmacy Services Inc. is recalling 1,762 fentanyl syringes nationwide due to lack of assurance of sterility. No illnesses or injuries have been reported.

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 a sterile injectable product due to lack of sterility assurance, presenting a significant risk of contamination and infection. No illnesses or injuries have been reported, classifying it as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Central Admixture Pharmacy Services Inc. is recalling fentanyl in 0.9% sodium chloride, 10 mcg/1 mL, in 3 mL syringes distributed nationwide. The recall affects 1,762 syringes with NDC 71286-2071-7.

The recall is due to a lack of assurance of sterility. Affected lot numbers are 17-275858 (expiration 10/11/2023), 17-275967, and 17-275981 (expiration 10/15/2023).

Healthcare providers and dispensing facilities should identify and quarantine affected syringes. Patients who have received these syringes should contact their healthcare provider. No illnesses or injuries have been reported as of the recall announcement.

The recalled product

Product
fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-7
Manufacturer
Central Admixture Pharmacy Services Inc
Hazard
  • lack-of-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 (5)

  • Lot: 17-275858
  • Exp. 10/11/2023
  • 17-275967
  • 17-275981
  • Exp. 10/15/2023

Distribution

Distributed nationwide across the United States.