Lidocaine-Epinephrine Injectable Solution Recalled for Sterility Assurance Issues
Vital Care Compounder is recalling 7 syringes of Lidocaine-Epinephrine solution due to lack of sterility assurance. FDA inspection found the products cannot be guaranteed to be sterile.
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 recall of a sterile injectable pharmaceutical product with unassured sterility. The hazard is theoretical with no reported illnesses or injuries; per the rubric rule for theoretical hazards with no reported illness, the severity is capped at High.
Plain-English summary
Vital Care Compounder is recalling 7 syringes of Lidocaine-Epinephrine Buffered 2%/1:1000 Solution (10 mL syringes). According to FDA inspection, the products were manufactured in a manner that cannot guarantee their sterility.
The recalled product was distributed in Alabama, Louisiana, Mississippi, and Tennessee. The affected lot number is 66591 with a Beyond-Use Date (BUD) of 11/12/2022.
Healthcare providers and pharmacies should discontinue use of the recalled product. Any remaining syringes should be returned to Vital Care Compounder or disposed of according to pharmaceutical waste guidelines.
The recalled product
- Product
- LIDOCAINE EPINEPHRINE BUFFERED 2%/1:1000 Solution, 10 mL syringe, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
- Manufacturer
- Pharmacy Plus, Inc. dba Vital Care Compounder
- Affected units
- 7
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: 66591
- BUD: 11/12/2022
Distribution
Part of a larger recall action
This product is one of 32 recalled by Pharmacy Plus, Inc. dba Vital Care Compounder 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.
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