Lidocaine Injection Recall Due to Hair Contamination
Fresenius Kabi is recalling lidocaine injection vials after hair was found in the product. The recall affects 181,225 vials distributed nationwide.
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 involving a sterile injectable drug with particulate contamination (hair), which poses a risk of harm if administered to patients. No illnesses or injuries have been reported at this time, so the score is capped at 3 per the rubric.
Plain-English summary
Fresenius Kabi USA, LLC is recalling Lidocaine HCl Injection, USP, 2%, 100 mg per 5 mL, sold in 25 single-dose vials per tray. The product is being recalled due to the presence of particulate matter, specifically hair found in the product.
The recalled product
- Product
- LIDOCAINE (LIDOCAINE HYDROCHLORIDE)
- Brand
- LIDOCAINE
- Manufacturer
- Fresenius Kabi USA, LLC
- Category
- Drug — Injectable / Sterile
- Affected units
- 181,225
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 #: 6133801
- Exp. Date 01/2028
UPCs (1)
- 0363323208011
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 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.
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