FDAClass IIDecember 18, 2019

Vancomycin Hydrochloride for Injection recall

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.

Why was Vancomycin Hydrochloride for Injection recalled?

Discoloration: Product complaints of discoloration after reconstitution of vials.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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.
Recalling firm
AuroMedics Pharma LLC
Quantity
275,060 vials
Distribution
Nationwide in the USA
Recall date
December 18, 2019
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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