The Recall Desk
HighFDA (Drugs)·D-0128-2023·Announced 2023-01-25

Prescription Anesthetic Drug Recalled for Subpotent Epinephrine Content

Fresenius Kabi is recalling Sensorcaine anesthetic injections nationwide due to subpotent epinephrine content. Affected batches may not provide adequate anesthesia or hemostasis during procedures.

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 involving risk-of-harm product (subpotent local anesthetic may cause inadequate anesthesia or hemostasis) with no reported illnesses or injuries. Per rubric, risk-of-harm without reported injury scores as High (3).

Plain-English summary

Fresenius Kabi USA, LLC is recalling Sensorcaine (Bupivacaine HCl and Epinephrine Bitartrate Injection, USP) 0.5%, in 50 mL multiple-dose vials. The recall affects 40,025 vials distributed nationwide.

Testing results for the epinephrine component of the recalled product fell below the defined limit. This deficiency may result in inadequate hemostasis (blood clotting control) or insufficient duration of local anesthesia during medical procedures.

Healthcare providers should immediately quarantine and discontinue use of the affected batches: 6128399, 6128400, and 6128401 (expiration April 2024). Patients and providers should report any adverse events or concerns related to these batches to Fresenius Kabi or the FDA.

The recalled product

Product
SENSORCAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE)
Brand
SENSORCAINE
Manufacturer
Fresenius Kabi USA, LLC
Category
Drug — Injectable Local Anesthetic
Hazard
Affected units
40,025

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 (4)

  • Batch #: 6128399
  • 6128400
  • 6128401
  • exp 04/2024

UPCs (6)

  • 0363323472030
  • 0363323461010
  • 0363323463014
  • 0363323468026
  • 0363323472016
  • 0363323468019

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Fresenius Kabi USA, LLC 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 3 products in this recall →

Related recalls

Same brand · SENSORCAINE

Same manufacturer · Fresenius Kabi USA, LLC

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Same hazard · subpotent epinephrine

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