Reported Jul 14, 2021 · Terminated
Xylocaine-MPF with Epinephrine 1:200,000, (Lidocaine HCl and Epinephrine Injection, USP), 1%, 300 mg/30 mL, (10 mg/mL),…
Fresenius Kabi USA LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Fresenius Kabi USA LLC · 2020 N Ruby St · Melrose Park, IL · 60160-1112
Is this the product you have?
- Xylocaine-MPF with Epinephrine 1
200000(Lidocaine HCl and Epinephrine InjectionUSP)1%300 mg/30 mL(10 mg/mL)30 mL Single Dose Vial25 Vials per TrayRx onlyFresenius Kabi USALLCLake ZurichIL 60047. Vial NDC 63323-487-07Tray NDC 63323-487-37
- Lot codes and dates
- Batch
- expiry
Batch 6123435exp 01/202261247306124731exp 07/2022
- Amount recalled
- 234,800 vials
Where it was sold
- Nationwide
Why it was recalled
Low out of specification results for epinephrine assay.
This product could cause temporary or reversible health problems — stop using it.
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