The Recall Desk
HighFDA (Drugs)·D-0011-2024·Announced 2023-10-11

Fentanyl Injection Recalled Due to Lack of Sterility Assurance

Central Admixture Pharmacy Services Inc. is recalling 688 units of fentanyl injection nationwide because it cannot assure the product meets sterility standards.

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 a sterility assurance issue. The hazard poses a risk of infection, but no hospitalizations or illnesses have been reported. The score reflects that this is a risk-of-harm product in the absence of documented injuries.

Plain-English summary

Central Admixture Pharmacy Services Inc. is recalling 688 50-milliliter syringes of fentanyl injection (10 mcg/mL). The product was distributed nationwide in the United States. The recall was initiated because the manufacturer cannot assure that the product meets sterility standards.

The affected product is identified by lot numbers 17-275341 (expires October 3, 2023) and 17-275853 (expires October 11, 2023).

The recalled product

Product
fentaNYL in 0.9% sodium chloride, 500 mcg/50 mL, (10 mcg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-3
Manufacturer
Central Admixture Pharmacy Services Inc
Hazard
  • sterility

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: 17-275341
  • Exp. 10/3/2023
  • 17-275853
  • Exp. 10/11/2023

Distribution

Distributed nationwide across the United States.