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Recall Observatory FDA recall evidence

Drug 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

D-1248-2019

March 28, 2019

Class I

Product summary

Firm
Aurobindo Pharma USA Inc.
Event
Event 82496
Status
Terminated
Classification
Class I
Quantity
88600 vials
Official record key
drug-enforcement:D-1248-2019

Official wording

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

Code information: Lot #: CLC180117, Exp. June 2021

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.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter