The Recall Desk
HighFDA (Drugs)·D-1072-2023·Announced 2023-08-09

Fentanyl-bupivacaine injectable drug recalled due to sterility concerns

Central Admixture Pharmacy Services is recalling 896 bags of fentanyl-bupivacaine injectable solution nationwide due to lack of sterility assurance. The FDA Class II recall affects compounded pain medication lacking adequate sterilization validation.

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 FDA Class II recall involves an injectable medication with sterility assurance issues, representing a potential risk of serious infection in patients. No illnesses or injuries have been reported; the hazard is based on lack of validation data rather than confirmed contamination.

Plain-English summary

Central Admixture Pharmacy Services Inc. is recalling fentanyl 2 mcg/mL and bupivacaine 0.125% injectable solution in 250 mL bags distributed nationwide. A total of 896 bags are affected.

The FDA issued a Class II recall due to lack of assurance of sterility. The manufacturer lacks adequate validation data for sanitization cycles used in the compounding process. Affected lots include lot 17-270540 (expiration 7/16/2023) through lot 17-274414 (expiration 9/18/2023).

Healthcare facilities and pharmacies that received affected lots should identify and cease use of the medication immediately. Patients currently receiving this medication should contact their healthcare provider to discuss alternative pain management options. Do not use any remaining doses of the recalled medication.

The recalled product

Product
fentaNYL 2 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride / Total Volume = 250 mL, Total fentaNYL 500 mcg/250 mL, bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2082-2
Manufacturer
Central Admixture Pharmacy Services Inc
Category
Drug — Injectable / Compounded
Hazard
Affected units
896

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: 17-270540
  • Exp. 7/16/2023
  • 17-270663
  • Exp. 7/18/2023
  • 17-271059
  • Exp. 7/24/2023
  • 17-271249
  • Exp. 7/26/2023
  • 17-271593
  • Exp. 8/1/2023
  • 17-271742
  • Exp. 8/3/2023
  • 17-272064
  • Exp. 8/9/2023
  • 17-272106
  • Exp. 8/10/2023
  • 17-272279
  • Exp. 8/14/2023
  • 17-272530
  • Exp. 8/17/2023

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 39 recalled by Central Admixture Pharmacy Services Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 39 products in this recall →

Related recalls

Same manufacturer · Central Admixture Pharmacy Services Inc

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Same hazard · sterility

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