FDAClass IJune 19, 2024

Docetaxel Injection recall: Particulate Matter

Docetaxel Injection, USP, 80 mg per 8 mL (10 mg per mL), 1 x 8 mL Multi-Dose Vial, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195…

Why was Docetaxel Injection recalled?

Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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 #: F1040001, Exp. Date 12/31/2024

Product
Docetaxel Injection, USP, 80 mg per 8 mL (10 mg per mL), 1 x 8 mL Multi-Dose Vial, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195…
Recalling firm
Sagent Pharmaceuticals
Quantity
762 vials
Distribution
Nationwide within the USA.
Recall date
June 19, 2024
Classification
Class I
Status
Ongoing
Agency
FDA (drug)
Open FDA enforcement record Latest recalls