AuroMedics Pharma LLC recalls Vancomycin Hydrochloride for Injection, USP, 1 g* per vial, packaged in 10-count vials per carton, Rx only, Mft. in Ind…
- Recall date
- November 25, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0574-2020
- FDA classification
- Class II
- Brand / firm
- AuroMedics Pharma LLC
- Sold / distributed
- Nationwide in the USA
Why it was recalled
Discoloration: Product complaints of discoloration after reconstitution of vials.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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