Xylocaine Lidocaine Injection Recalled for Low Epinephrine Assay Results
Fresenius Kabi USA LLC is recalling Xylocaine-MPF with Epinephrine 1:200,000 injection vials nationwide due to low out-of-specification results for epinephrine assay.
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: This is an FDA Class II recall. The source states only that epinephrine assay results were "low out of specification" with no reported illnesses, injuries, or deaths. This is a pharmaceutical quality issue without evidence of harm.
Plain-English summary
Fresenius Kabi USA LLC is recalling Xylocaine-MPF with Epinephrine 1:200,000 (Lidocaine HCl and Epinephrine Injection, USP) 1%, 300 mg/30 mL, 30 mL single-dose vials due to low out-of-specification results for epinephrine assay. The affected product consists of 234,800 vials distributed nationwide in the USA.
The affected lots are: Batch 6123435 (expiration 01/2022), Batch 6124730 (expiration 07/2022), and Batch 6124731 (expiration 07/2022). Healthcare providers and patients who have received this product should consult with their healthcare provider regarding their use of the recalled vials.
Consumers and healthcare facilities with these vials should stop use and contact Fresenius Kabi USA LLC or the FDA for further instructions on return or disposal of the affected product.
The recalled product
- Product
- XYLOCAINE (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE)
- Brand
- XYLOCAINE
- Manufacturer
- Fresenius Kabi USA LLC
- Affected units
- 234,800
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 (6)
- Batch
- expiry: Batch 6123435
- exp 01/2022
- 6124730
- 6124731
- exp 07/2022
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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