The Recall Desk
SevereFDA (Drugs)·D-1248-2019·Announced 2019-04-17

Aurobindo Recalls MARBETA L KIT Vials Due to Particulate Matter

Aurobindo Pharma USA Inc. is recalling 88,600 vials of MARBETA L KIT because one vial was found to contain a hair.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric.

Plain-English summary

Aurobindo Pharma USA Inc. is recalling 88,600 vials of MARBETA L KIT (Lot CLC180117, Exp. June 2021). The recall was initiated because one vial was found to contain a hair, which constitutes the presence of particulate matter.

The affected product is Lidocaine HCl Injection, USP 1 % 50 mg/5 mL (10 mg/mL), 5mL vial. The product is being held at distributor sites in Mexico, Asheboro, NC, Charlotte, NC, and Santa Teresa, NM, and has not been further distributed in the U.S. market.

Consumers and healthcare providers should check their inventory for this specific lot number and expiration date. If the product is found, it should be quarantined and not used.

The recalled product

Product
MARBETA L KIT (BETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOL)
Brand
MARBETA L KIT
Affected units
88,600

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot #: CLC180117
  • Exp. June 2021

Distribution

Distribution scope not specified by the agency.