FDAFDA · Food and drugs·Recall number D-0651-2021
Xylocaine-MPF with Epinephrine 1:200,000, (Lidocaine HCl and Epinephrine Injection, USP), 1%, 300 mg/30 mL, (10 mg/mL), 30 mL Single Dose Vial, 25 Vials per Tray, Rx only, Fresenius Kabi USA, LLC, Lake Zurich, IL 60047. Vial NDC 63323-487-07, Tray NDC 63323-487-37
Published July 14, 2021 · Recall initiated: June 25, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Low out of specification results for epinephrine assay.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- XYLOCAINE
- Manufacturer
- Fresenius Kabi USA LLC
- Distributor
- Distributed Nationwide in the USA
- UPC
- 0363323484576
- Lot
- Batch, expiry: Batch 6123435, exp 01/2022; 6124730, 6124731, exp 07/2022
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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