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Class I · Most seriousRecall completed

Marbeta L Kit

A reasonable chance it could cause serious harm or death.

Does this affect you?
Check your lot numberLot #: CLC180117, Exp. June 2021
Where it was soldProduct 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.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Presence of Particulate Matter: One vial was found to contain a hair.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byAsclemed USA, Inc.
Brand nameMARBETA L KIT
Generic nameBETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOL
Distributed by / forAurobindo Pharma USA Inc.
NDC55150-162-05
Show the full FDA record
Full product labelLidocaine 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
Recalling firmAurobindo Pharma USA Inc.
DistributionProduct 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.
Quantity88600 vials
Recall initiated2019-03-28
Report date2019-04-17
Recall completed2024-04-11
Recall numberD-1248-2019
ClassificationClass I
FDA statusTerminated
Origin on fileEast Windsor NJ United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.