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
- 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
Same brand · SENSORCAINE
- HighPrescription Anesthetic Drug Recalled for Subpotent Epinephrine Content
FDA (Drugs) · 2023-01-25
- HighInjectable Anesthetic Sensorcaine Recalled for Subpotent Epinephrine
FDA (Drugs) · 2023-01-25
- ModerateFresenius Kabi Recalls Sensorcaine Due to Low Epinephrine Levels
FDA (Drugs) · 2020-12-30
- SevereFresenius Kabi Recalls Sensorcaine Due to Glass Particulate Matter
FDA (Drugs) · 2016-06-22
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