Marbeta L Kit
FDA Recall NDC 76420-782
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 Marbeta L Kit (NDC 76420-782). A significant event, classified as Class I, was initiated on Mar 28, 2019 by Asclemed Usa, Inc.. The reported reason for this action was: "Presence of Particulate Matter: One vial was found to contain a hair."
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 I Terminated
Presence of Particulate Matter: One vial was found to contain a hair.
Mar 28, 2019
Apr 17, 2019
88600 vials
Recall Profile & Regulatory Data
Event ID
82496
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Aurobindo Pharma USA Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product is being held at a distributor site in Mexico, Asheboro, NC, Charlotte, NC and Santa Teresa, NM and not further distributed in the U.S. Market.
Termination Date
Apr 11, 2024
Product Description
Lidocaine HCl Injection, USP 1 % 50 mg/5 mL (10 mg/mL), 5mL vial, Rx only, Mrd. in India for: AuroMedics Pharna LLC. E Windsor, NJ 08520 NDC 55150-162-05
Batch or Lot Expiration Information
Lot# : CLC180117, Exp. June 2021
Affected Packages Involved in this Recall
76420-782-01Product
0517-0720-01Product
55150-162-05Product
0409-1159-18Product
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.
