The Recall Desk
HighFDA (Drugs)·D-1063-2023·Announced 2023-08-09

Fentanyl Injectable Recalled for Lack of Sterility Assurance

Central Admixture Pharmacy Services is recalling 1,044 bags of fentanyl injectable solution due to lack of validated sanitization procedures that could compromise sterility assurance. The product affects healthcare facilities nationwide.

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 opioid product due to lack of validated sanitization procedures. Fentanyl is a risk-of-harm product, and while no illnesses or injuries have been reported, the potential for serious harm from non-sterile injections meets the High severity criterion.

Plain-English summary

Central Admixture Pharmacy Services Inc is recalling 1,044 bags of fentanyl injectable solution (5000 mcg/250 mL). The product is supplied in sterile preparation bags for intravenous use and was distributed nationwide.

The manufacturer and FDA identified that the product lacks adequate assurance of sterility. Specifically, the sanitization cycles used in manufacturing lack validation data to ensure they are effective.

Fentanyl is a potent opioid used in clinical and hospital settings. Any potential compromise to sterility could pose a risk to patients who receive the product.

Healthcare facilities that received this product should stop using it and follow the recall instructions provided by Central Admixture Pharmacy Services Inc. Healthcare providers should monitor any patients who may have received fentanyl from these affected lots.

The recalled product

Product
fentaNYL in 0.9% sodium chloride, 5000 mcg/250 mL, (20 mcg/mL), 250 mL Bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2074-1
Manufacturer
Central Admixture Pharmacy Services Inc
Category
Drug — Compounded Injectable
Hazard
  • sterility-assurance
  • 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 (20)

  • Lot: 17-271115
  • Exp. 7/25/2023
  • 17-271398
  • Exp. 7/30/2023
  • 17-272278
  • Exp. 8/14/2023
  • 17-272449
  • Exp. 8/16/2023
  • 17-272521
  • Exp. 8/17/2023
  • 17-272900
  • Exp. 8/23/2023
  • 17-273146
  • Exp. 8/29/2023
  • 17-273236
  • Exp. 8/30/2023
  • 17-273404
  • Exp. 9/3/2023
  • 17-273678
  • Exp. 9/6/2023

Distribution

Distributed nationwide across the United States.

Related recalls

Same category