Xylocaine Injection Recall Due to Hair Contamination
Fresenius Kabi is recalling 93,250 vials of Xylocaine (lidocaine HCl) injection due to the presence of particulate matter, specifically hair found in the product.
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: FDA Class II recall involving particulate matter (hair) in an injectable drug product. While no illnesses or injuries have been reported, injectable products with foreign particle contamination pose a risk of harm if administered to patients.
Plain-English summary
Fresenius Kabi USA, LLC is recalling 93,250 vials of XYLOCAINE (lidocaine hydrochloride, epinephrine bitartrate) injection, 1%, 200 mg per 20 mL, in 25 multiple-dose vials. The product was distributed nationwide within the USA.
The recall is due to the presence of particulate matter, specifically hair found in the products. The affected lot number is 6130235 with an expiration date of 02/2027.
Healthcare providers and consumers who received the affected product should immediately check their inventory, quarantine any remaining units, and contact Fresenius Kabi to arrange for return or replacement. No illnesses or injuries have been reported in connection with this recall.
The recall was initiated as a precautionary measure after routine testing identified the presence of hair contamination in the injectable product.
The recalled product
- Product
- XYLOCAINE (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE)
- Brand
- XYLOCAINE
- Manufacturer
- Fresenius Kabi USA, LLC
- Category
- Drug — Injectable Anesthetic
- Hazard
- particulate-matter
- foreign-contamination
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 #: 6130235
- Exp. Date 02/2027
UPCs (14)
- 0363323484576
- 0363323485016
- 0363323483036
- 0363323487072
- 0363323486013
- 0363323495091
- 0363323488079
- 0363323489021
- 0363323495046
- 0363323491017
- 0363323492045
- 0363323492090
- 0363323482015
- 0363323481018
Distribution
Distributed nationwide across the United States.
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