FDA-Drug2019-12-18Class II
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.
AuroMedics Pharma LLC
Hazard
Discoloration: Product complaints of discoloration after reconstitution of vials.
Sold states
Nationwide in the USA
Affected count
275,060 vials
Manufactured in
279 Princeton Hightstown Rd, N/A, East Windsor, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0574-2020Don't want to check this manually?
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