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Vancomycin Hydrochloride for Injection, USP, 1 g* per vial, packaged in 10-count vials per carton...

FDA Recall #D-0574-2020 — Class II — November 25, 2019

Recall #D-0574-2020 Date: November 25, 2019 Classification: Class II Status: Terminated

Product Description

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.

Recalling Firm

AuroMedics Pharma LLC — East Windsor, NJ

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

275,060 vials

Distribution

Nationwide in the USA

Code Information

Lot #: CVM180003, CVM180004, Exp 04/2020; CVM180008, Exp 07/2020; CVM180009, CVM180010, CVM180011, CVM180012, Exp 09/2020

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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