Fresenius Kabi Recalls Sensorcaine Due to Glass Particulate Matter
Fresenius Kabi is recalling specific lots of Sensorcaine injection because glass particulate matter was found in the sterile product.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for significant injury or property damage reports or high-risk contamination.
Plain-English summary
Fresenius Kabi USA, LLC is recalling 69,225 units of Sensorcaine (Bupivacaine Hydrochloride and Epinephrine Bitartrate) 0.75% in 30 mL single-dose vials. The recall was initiated because glass particulate matter was found in the sterile injectable product.
The affected product is identified by Lot # 6111504 with an expiration date of 09/2019. The product is distributed nationwide. Sensorcaine is a prescription drug used for infiltration and perineural routes.
Healthcare providers and patients should stop using the affected lots and contact Fresenius Kabi USA, LLC for further instructions or replacement.
The recalled product
- Product
- SENSORCAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE)
- Brand
- SENSORCAINE
- Manufacturer
- Fresenius Kabi USA, LLC
- Category
- Drug — Injectable Anesthetic
- Affected units
- 69,225
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)
- Lot #: 6111504
- Exp 09/2019
UPCs (6)
- 0363323472030
- 0363323461010
- 0363323463014
- 0363323468026
- 0363323472016
- 0363323468019
Distribution
Distributed nationwide across the United States.
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