The Recall Desk
HighFDA (Drugs)·D-1062-2023·Announced 2023-08-09

Fentanyl Injectable Syringes Recalled for Sterility Assurance Concerns

Central Admixture Pharmacy Services is recalling 2,340 fentanyl syringes distributed nationwide due to lack of sterility assurance from unvalidated sanitization procedures.

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 recall of a high-risk injectable medication (fentanyl) where sterility assurance is compromised due to unvalidated sanitization procedures. No illnesses or injuries have been reported; the hazard is potential contamination that could cause serious infection if the product was compromised.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling fentanyl in 0.9% sodium chloride (10 mcg/1 mL) supplied in 3 mL syringes. The recall affects 2,340 units distributed nationwide in the USA.

The recall was issued because the manufacturer lacked validation data for the sanitization cycles used during manufacturing. This insufficient validation means sterility of the product cannot be assured.

The affected lot numbers are 17-270813 (expiration 7/19/2023), 17-271485 (7/31/2023), 17-271809 (8/6/2023), 17-272314 (8/14/2023), 17-272780 (8/22/2023), 17-273141 (8/29/2023), and 17-273687 (9/6/2023). The product is distributed under NDC 71286-2071-7.

Healthcare providers and patients should stop using affected syringes immediately. Units with these lot numbers should be removed from use and returned to the manufacturer if possible. Contact Central Admixture Pharmacy Services or the FDA with any questions about this recall.

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
Category
Drug — Injectable / Fentanyl
Hazard
  • lack-of-sterility
  • contamination-risk

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 (14)

  • Lot: 17-270813
  • Exp. 7/19/2023
  • 17-271485
  • Exp. 7/31/2023
  • 17-271809
  • Exp. 8/6/2023
  • 17-272314
  • Exp. 8/14/2023
  • 17-272780
  • Exp. 8/22/2023
  • 17-273141
  • Exp. 8/29/2023
  • 17-273687
  • Exp. 9/6/2023.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category