FDAClass IApril 20, 2022

IDArubicin Hydrochloride Injection USP 5gm/5mL recall: Particulate Matter

IDArubicin Hydrochloride Injection USP 5gm/5mL (1mg/mL) for intravenous use, 5mL Single Dose Vial, Rx Only, Teva Pharmaceuticals, USA, Inc., North…

Why was IDArubicin Hydrochloride Injection USP 5gm/5mL recalled?

Presence of Particulate Matter: Product was found to contain silica and iron oxide

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 #: 31329657B, Exp. Date 08/2023

Product
IDArubicin Hydrochloride Injection USP 5gm/5mL (1mg/mL) for intravenous use, 5mL Single Dose Vial, Rx Only, Teva Pharmaceuticals, USA, Inc., North…
Recalling firm
Teva Pharmaceuticals USA Inc
Quantity
1565 vials
Distribution
Nationwide within the United States
Recall date
April 20, 2022
Classification
Class I
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls