The Recall Desk
HighFDA (Drugs)·D-1070-2023·Announced 2023-08-09

Fentanyl and Bupivacaine Injectable Recalled for Sterility Concerns

Central Admixture Pharmacy Services is recalling 1,114 bags of fentanyl and bupivacaine injectable due to lack of validation data for sterilization. The product was distributed 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: FDA Class II recall of a sterile injectable with no reported illnesses or injuries. The hazard—lack of sterilization validation—is theoretical, not confirmed contamination. This meets the rubric criteria for High (score 3): risk-of-harm products where injury has not yet been reported.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling 1,114 bags of a compounded injectable medication containing fentaNYL 2 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride (100 mL bags, NDC 71286-2082-1) that was distributed nationwide.

The recall is due to lack of validation data for sanitization cycles, which means the manufacturer cannot assure the sterility of the product. Compounded sterile injectables require validated sterilization procedures to prevent microbial contamination.

Healthcare providers and facilities should check their inventory for the affected lot numbers. Those who have received affected product should follow guidance from the FDA and the manufacturer regarding product disposition.

The recalled product

Product
fentaNYL 2 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride, Total Volume = 100 mL, Total FentaNYL 200 mcg/100 mL, 100 mL bag, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2082-1
Manufacturer
Central Admixture Pharmacy Services Inc
Category
Drug — Compounded Injectable
Hazard
  • lack-of-sterility
  • contamination

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 (17)

  • Lot: 17-274485
  • Exp. 9/19/2023
  • 17-270783
  • Exp. 7/19/2023
  • 17-270882
  • Exp. 7/20/2023
  • 17-271430
  • Exp. 7/30/2023
  • 17-271509
  • Exp. 7/31/2023
  • 17-272224
  • 17-272238
  • Exp. 8/13/2023
  • 17-272704
  • Exp. 8/21/2023
  • 17-273147
  • Exp. 8/29/2023.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category