The Recall Desk
HighFDA (Drugs)·D-0129-2023·Announced 2023-01-25

Local anesthetic Sensorcaine vials recalled for subpotent epinephrine

Fresenius Kabi is recalling Sensorcaine-MPF local anesthetic vials due to subpotent epinephrine levels. The affected batch (31,600 vials) 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: This is an FDA Class II drug recall where the product is subpotent—a risk-of-harm scenario in which the local anesthetic may not work as intended. No illnesses or injuries are reported in the source text, placing this within the 'High' severity tier per the rubric criterion for risk-of-harm products without reported injury.

Plain-English summary

Fresenius Kabi USA, LLC is recalling Sensorcaine-MPF (bupivacaine HCl and epinephrine injection) due to subpotent epinephrine levels. The affected batch (6128800) contains 31,600 vials with an expiration date of December 2023 and was distributed nationwide in the United States.

Sensorcaine is a local anesthetic administered for infiltration and perineural injection. Testing revealed that the epinephrine concentration in this batch was below the defined limit for the product.

The recalled product

Product
SENSORCAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE)
Brand
SENSORCAINE
Manufacturer
Fresenius Kabi USA, LLC
Category
Drug — Local Anesthetic
Hazard
  • subpotency

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 (2)

  • Batch #: 6128800
  • exp 12/2023

UPCs (6)

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

Distribution

Distributed nationwide across the United States.

Related recalls

Same brand · SENSORCAINE

Same category