March 2019 FDA Recall Marbeta L Kit by Aurobindo Pharma Usa Inc.
D-1248-2019 - Presence of Particulate Matter

This Class I drug recall was voluntarily initiated by Aurobindo Pharma Usa Inc. on March 28, 2019 for the product Marbeta L Kit. The FDA reported the reason for recall as presence of particulate matter. The product was distributed in 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. and the recall is currently terminated.

Recall Number: D-1248-2019

Reason for Recall
Presence of Particulate Matter: One vial was found to contain a hair.
Initiated
03-28-2019
Reported
04-17-2019
Quantity
88600 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82496
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Aurobindo Pharma USA Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
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 About Termination Date
Date that FDA officially terminated the recall.
04-11-2024
Product Description About Product Description
Full technical description of the product.
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

76420-782-01 Marbeta L Kit