Injectable Anesthetic Sensorcaine Recalled for Subpotent Epinephrine
Sensorcaine injectable anesthetic is being recalled because testing showed the epinephrine component is below the required potency level. No illnesses or injuries have been reported.
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 recall for a subpotent drug where the epinephrine concentration is below required limits. No illnesses or injuries have been reported, but the defect represents a risk of harm if inadequate potency compromises anesthetic effectiveness.
Plain-English summary
Sensorcaine (bupivacaine hydrochloride and epinephrine injection, USP) is a prescription injectable anesthetic with a vasconstrictor component. Fresenius Kabi USA is recalling 40,375 vials distributed nationwide, specifically 50 mL multiple-dose vials (NDC 63323-461-01).
Testing results indicated that the epinephrine portion of this product is below the defined potency limit, making it subpotent. Affected batches are: Batch #6128061 (expiring March 2024) and Batches #6128663 and #6128664 (expiring May 2024).
No illnesses or injuries have been reported. Healthcare providers should check their inventory for the affected batch numbers and discontinue use of any recalled product.
The recalled product
- Product
- SENSORCAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE)
- Brand
- SENSORCAINE
- Manufacturer
- Fresenius Kabi USA, LLC
- Category
- Drug — Injectable Anesthetic
- Hazard
- subpotent
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 (5)
- Batch #: 6128061
- exp 03/2024
- 6128663
- 6128664
- exp 05/2024
UPCs (6)
- 0363323472030
- 0363323461010
- 0363323463014
- 0363323468026
- 0363323472016
- 0363323468019
Distribution
Distributed nationwide across the United States.
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