FDAClass IIJuly 14, 2021

Xylocaine-MPF with Epinephrine 1:200 recall

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…

Why was Xylocaine-MPF with Epinephrine 1:200 recalled?

Low out of specification results for epinephrine assay.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
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…
Recalling firm
Fresenius Kabi USA LLC
Quantity
234,800 vials
Distribution
Distributed Nationwide in the USA
Recall date
July 14, 2021
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls