FDA recall D-0574-2020

Product

Vancomycin Hydrochloride for Injection, USP, 1 g* per vial, packaged in 10-count vials per carton, Rx only, Mft. in India for: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-204-20.

Reason for recall

Discoloration: Product complaints of discoloration after reconstitution of vials.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2019-11-25

Report date

2019-12-18

Termination date

2021-03-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

East Windsor, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0574-2020