The Recall Desk
HighFDA (Drugs)·D-1043-2023·Announced 2023-08-09

Fentanyl injection syringes recalled for unvalidated sterilization process

Central Admixture Pharmacy Services is recalling 5,124 fentanyl syringes because the manufacturer lacks validation that its sterilization process is effective. The nationwide recall affects multiple lot numbers distributed through September 2023.

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 injectable medication with unvalidated sterilization processes, presenting a potential contamination risk. No illnesses or injuries are mentioned in the source document, supporting the criterion for 'risk-of-harm products where injury has not yet been reported' (score 3).

Plain-English summary

Central Admixture Pharmacy Services Inc. is recalling 5,124 fentanyl syringes (1250 mcg/25 mL, 50 mcg/mL) distributed nationwide. The recall is due to a lack of validation data for the sanitization cycles used to sterilize the product.

Without proper validation that the sterilization process works, there is no assurance that the syringes are sterile. Lack of sterilization in injectable medications presents a potential contamination risk.

The affected syringes have lot numbers ranging from 17-270664 through 17-274208, with expiration dates from July 2023 through September 2023. The manufacturer's NDC is 71286-2003-7. Patients and healthcare providers who have these syringes should discontinue use and contact the manufacturer or the FDA with questions.

The recalled product

Product
fentaNYL, 1250 mcg/25 mL, (50 mcg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-7
Manufacturer
Central Admixture Pharmacy Services Inc
Category
Drug — Injectable / Fentanyl
Hazard
  • contamination
  • 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 (20)

  • Lot: 17-270664
  • Exp. 7/18/2023
  • 17-270886
  • Exp. 7/20/2023
  • 17-270976
  • 17-270989
  • Exp. 7/23/2023
  • 17-271335
  • Exp. 7/27/2023
  • 17-271572
  • Exp. 8/1/2023
  • 17-271747
  • Exp. 8/3/2023
  • 17-271808
  • Exp. 8/6/2023
  • 17-272023
  • Exp. 8/9/2023
  • 17-272203
  • Exp. 8/13/2023
  • 17-272718

Distribution

Distributed nationwide across the United States.

Related recalls

Same category