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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 31,600
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.
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
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