Marlido Kit
FDA Recall NDC 80425-0573
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Marlido Kit (NDC 80425-0573). A significant event, classified as Class II, was initiated on Nov 11, 2019 by Advanced Rx Of Tennessee, Llc. The reported reason for this action was: "Presence of Foreign Substance: Foreign material found inside the vial."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Presence of Foreign Substance: Foreign material found inside the vial.
Nov 11, 2019
Dec 04, 2019
111,850 vials
Recall Profile & Regulatory Data
Event ID
84241
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
AuroMedics Pharma LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Nov 17, 2020
Product Description
Lidocaine HCl Injection, USP, 2% 100 mg/5 mL (20 mg/mL), Preservative-Free, packaged in 10 x 5 mL Single Dose Vials per carton, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520, NDC 55150-165-05.
Batch or Lot Expiration Information
Batch# : CLC190049, Exp 02/2022
Affected Packages Involved in this Recall
80425-0573-1Product
0409-1162-18Product
55150-165-05Product
67777-419-02Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
