Drug recall D-1248-2019

Class I Terminated reported Apr 17, 2019

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

Reason for recall

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

Lots and codes

Lot #: CLC180117, Exp. June 2021

Recall details

Recalling firm
Aurobindo Pharma USA Inc., East Windsor, NJ
Quantity
88600 vials
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.
Type
Voluntary: Firm initiated
Recall initiated
March 28, 2019
Terminated
April 11, 2024

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