Fresenius Kabi Recalls Sensorcaine Due to Low Epinephrine Levels
Fresenius Kabi is recalling 4,411 trays of Sensorcaine (Bupivacaine HCl and Epinephrine) because the epinephrine component tested below specification.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity rating involving a subpotent drug.
Plain-English summary
Fresenius Kabi USA, LLC is recalling 4,411 trays of Sensorcaine (Bupivacaine Hydrochloride and Epinephrine Bitartrate) 0.5% injection. The product is identified by Batch # 6123760 with an expiration date of 02/2022. The recall was initiated because the epinephrine component produced low out-of-specification assay results, meaning the drug is subpotent.
The affected product is packaged as 25 single-dose vials per tray (NDC 63323-462-37) and was distributed nationwide in the USA. Sensorcaine is a prescription-only medication used for epidural and retrobulbar routes.
Healthcare providers and patients should stop using the affected product and contact Fresenius Kabi for further instructions or a replacement.
The recalled product
- Product
- SENSORCAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE)
- Brand
- SENSORCAINE
- Manufacturer
- Fresenius Kabi USA, LLC
- Category
- Drug — Injection
- Hazard
- Affected units
- 4,411
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 # 6123760
- Exp 02/2022
Distribution
Distributed nationwide across the United States.
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