June 2021 FDA Recall Xylocaine by Fresenius Kabi Usa Llc
D-0651-2021 - Low out of specification results for epinephrine assay.
This Class II drug recall was voluntarily initiated by Fresenius Kabi Usa Llc on June 25, 2021 for the product Xylocaine. The FDA reported the reason for recall as low out of specification results for epinephrine assay.. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0651-2021
Low out of specification results for epinephrine assay.
06-25-2021
07-14-2021
234,800 vials
Recall Profile & Regulatory Data
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Fresenius Kabi USA LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Distributed Nationwide in the USA
12-28-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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 Vials per Tray, Rx only, Fresenius Kabi USA, LLC, Lake Zurich, IL 60047. Vial NDC 63323-487-07, Tray NDC 63323-487-37
Batch or Lot Expiration Information
Batch# Batch, expiry: Batch 6123435, exp 01/2022; 6124730, 6124731, exp 07/2022
