The Recall Desk
HighFDA (Drugs)·D-1050-2023·Announced 2023-08-09

Fentanyl Injectable Solution Recalled for Unvalidated Sterilization Cycles

Central Admixture Pharmacy Services is recalling 848 bags of fentanyl injection nationwide due to lack of validated sterilization processes that assure product sterility. Multiple lots distributed to healthcare facilities are affected.

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 classification with a risk-of-harm product (injectable pharmaceutical) due to unvalidated sterilization processes creating potential contamination risk. No illnesses, injuries, or deaths are reported in the source, so per the rubric this meets the criteria for High (3) rather than Severe (4).

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling 848 bags of fentanyl injection (2500 mcg/50 mL, 50 mcg/mL, in 100 mL bags). The product was distributed nationwide.

The recall was initiated because validation data for sanitization cycles was not available, meaning the company cannot assure that the sterilization process was effective. This creates a potential risk that the distributed product may not be sterile and could be contaminated.

Affected lots include: 17-270533 (Exp. 7/16/2023), 17-270580 and 17-270581 (Exp. 7/17/2023), 17-270654 (Exp. 7/18/2023), 17-271044 (Exp. 7/24/2023), 17-271243 (Exp. 7/26/2023), 17-271439 (Exp. 7/30/2023), and 17-271562 (Exp. 8/1/2023). Healthcare facilities and pharmacies that received these lots should verify their inventory.

If your facility has received this product, do not use it. Contact Central Admixture Pharmacy Services, Inc. at 7935 Dunbrook Road, Suite C, San Diego, CA 92126, or notify the FDA for return instructions.

The recalled product

Product
fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 100 mL bag, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-4
Manufacturer
Central Admixture Pharmacy Services Inc
Category
Drug — Compounded Injectable
Hazard
  • sterility-failure
  • 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 (15)

  • Lot: 17-270533
  • Exp. 7/16/2023
  • 17-270580
  • 17-270581
  • Exp. 7/17/2023
  • 17-270654
  • Exp. 7/18/2023
  • 17-271044
  • Exp. 7/24/2023
  • 17-271243
  • Exp. 7/26/2023
  • 17-271439
  • Exp. 7/30/2023
  • 17-271562
  • Exp. 8/1/2023.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category