The Recall Desk
HighFDA (Drugs)·D-1054-2023·Announced 2023-08-09

Fentanyl Injectable Syringes Recalled for Lack of Sterility Assurance

Central Admixture Pharmacy Services is recalling approximately 2,082 fentanyl injectable syringes distributed nationwide due to lack of validation data for sanitization cycles, which cannot assure product 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: This is an FDA Class II recall driven by lack of sterilization assurance for an injectable pharmaceutical. The missing validation data for sanitization cycles represents a risk-of-harm situation, as inadequate sterilization of an injected medication could lead to serious infection or contamination.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling approximately 2,082 syringes of fentanyl in 0.9% sodium chloride (10 mcg/mL, 50 mL syringe). The product was distributed nationwide and is identified by NDC 71286-2071-3.

The recall was initiated due to lack of assurance of product sterility. The manufacturer lacks validation data for the sanitization cycles used to prepare the syringes. Without validated sanitization procedures, there is no documented evidence that the product meets sterility requirements.

Affected lot numbers include 17-271133, 17-271155, 17-271568, 17-271569, 17-271741, 17-271762, 17-272051, 17-272227, 17-272343, 17-272799, and 17-273495, with expiration dates from July 25, 2023 through September 4, 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
Category
Drug
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: 17-271133
  • 17-271155
  • Exp. 7/25/2023
  • 17-271568
  • 17-271569
  • Exp. 8/1/2023
  • 17-271741
  • 17-271762
  • Exp. 8/3/2023
  • 17-272051
  • Exp. 8/9/2023
  • 17-272227
  • Exp. 8/13/2023
  • 17-272343
  • Exp. 8/15/2023
  • 17-272799
  • Exp. 8/22/2023
  • 17-273173
  • Exp. 8/29/2023
  • 17-273495

Distribution

Distributed nationwide across the United States.

Related recalls

Same category