The Recall Desk
HighFDA (Drugs)·D-1047-2023·Announced 2023-08-09

Fentanyl Injectable Syringes Recalled Due to Sterility Assurance Failure

Central Admixture Pharmacy Services is recalling 1,216 fentanyl 2500 mcg/50 mL syringes distributed nationwide due to lack of validation data for sanitization cycles, which cannot assure sterility.

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 with no reported illnesses or injuries. The hazard involves potential contamination due to lack of sterility assurance for an injectable product, which represents a risk-of-harm product where injury has not yet been reported. Per the rubric, when no illnesses are reported and the hazard is theoretical, the maximum score is 3.

Plain-English summary

Central Admixture Pharmacy Services Inc. is recalling fentanyl 2500 mcg/50 mL (50 mcg/mL) syringes distributed nationwide. The affected product is supplied in 50 mL syringes with NDC 71286-2003-3, and 1,216 syringes are included in the recall.

The recall was initiated because the manufacturer lacked adequate validation data for sanitization cycles. Without proper validation, the sterility of the injectable product cannot be assured, which is critical for medications administered intravenously or intramuscularly.

Multiple lot numbers are affected by this recall, with expiration dates ranging from July 2023 through September 2023. Healthcare professionals should refer to the FDA recall notice for specific lot numbers and expiration dates.

The recalled product

Product
fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-3
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 (16)

  • Lot: 17-270771
  • Exp. 7/19/2023
  • 17-271134
  • Exp. 7/25/2023
  • 17-271577
  • Exp. 8/1/2023
  • 17-271745
  • Exp. 8/3/2023
  • 17-272026
  • Exp. 8/9/2023
  • 17-272345
  • Exp. 8/15/2023
  • 17-272615
  • Exp. 8/20/2023
  • 17-273668
  • Exp. 9/6/2023.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category