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Xylocaine-MPF with Epinephrine 1:200,000, (Lidocaine HCl and Epinephrine Injection, USP), 1%, 300...

FDA Recall #D-0651-2021 — Class II — June 25, 2021

Recall #D-0651-2021 Date: June 25, 2021 Classification: Class II Status: Terminated

Product Description

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

Reason for Recall

Low out of specification results for epinephrine assay.

Recalling Firm

Fresenius Kabi USA LLC — Melrose Park, IL

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

234,800 vials

Distribution

Distributed Nationwide in the USA

Code Information

Batch, expiry: Batch 6123435, exp 01/2022; 6124730, 6124731, exp 07/2022

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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