The Recall Desk
HighFDA (Drugs)·D-1069-2023·Announced 2023-08-09

Injectable Fentanyl-Bupivacaine Mixture Recalled for Sterility Validation Failure

Central Admixture Pharmacy Services recalls 295 bags of injectable fentanyl-bupivacaine solution nationwide because the sterilization process lacked proper validation documentation.

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 with no reported illnesses or injuries. The hazard is theoretical—a lack of validation data for sterilization rather than confirmed contamination. Per the rubric, risk-of-harm products without reported injury score as High (3).

Plain-English summary

Central Admixture Pharmacy Services Inc. is recalling 295 bags of a sterile injectable solution containing fentanyl 2 mcg/mL and bupivacaine 0.0625% in 0.9% sodium chloride. Each bag contains 250 mL (NDC 71286-2081-1) and is distributed nationwide in the United States.

The recall was initiated because the product lacks assurance of sterility. Specifically, the manufacturer has not provided validation data for the sanitization cycles used in preparing the product. Without this validation, there is no documented evidence that the sterilization process effectively eliminates microbial contaminants.

The affected lot numbers are: 17-271814 (Exp. 8/6/2023), 17-271960 (Exp. 8/8/2023), 17-272252 (Exp. 8/13/2023), 17-272272 (Exp. 8/14/2023), 17-272454 (Exp. 8/16/2023), 17-272640 (Exp. 8/20/2023), and 17-272716 (Exp. 8/21/2023). This injectable product is used in healthcare settings for regional anesthesia and pain management.

Healthcare providers should stop using affected lots immediately. For instructions on return, replacement, or other concerns, contact Central Admixture Pharmacy Services Inc. at 7935 Dunbrook Road, Suite C, San Diego, CA 92126.

The recalled product

Product
fentaNYL 2 mcg/mL and bupivacaine 0.0625% PF in 0.9% sodium chloride, Total Volume = 250 mL, Total fentaNYL 500 mcg/250 mL, 250 mL bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2081-1
Manufacturer
Central Admixture Pharmacy Services Inc
Category
Drug — Injectable Anesthetic
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 (14)

  • Lot: 17-271814
  • Exp. 8/6/2023
  • 17-271960
  • Exp. 8/8/2023
  • 17-272252
  • Exp. 8/13/2023
  • 17-272272
  • Exp. 8/14/2023
  • 17-272454
  • Exp. 8/16/2023
  • 17-272640
  • Exp. 8/20/2023
  • 17-272716
  • Exp. 8/21/2023.

Distribution

Distributed nationwide across the United States.

Related recalls

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