Aurobindo Pharma USA Inc. recalls Lidocaine HCl Injection, USP 1 % 50 mg/5 mL (10 mg/mL), 5mL vial, Rx only, Mrd. in India for: AuroMedics Pharna LLC. E…

Recall date

March 28, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1248-2019

FDA classification

Class I

Brand / firm

Aurobindo Pharma USA Inc.

Sold / distributed

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.

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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