Recall: D-0574-2020

Class II - Potentially Harmful

Class IIClassification

2019-11-25Initiated

TerminatedStatus

AuroMedics Pharma LLCFirm

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

Discoloration: Product complaints of discoloration after reconstitution of vials.

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.