FDAClass IIMarch 20, 2019

Docetaxel Injection USP recall: Sterility Concern

Docetaxel Injection USP, 80 mg/4 mL, (20 mg/mL), One-Vial Formulation, Rx only, Mfd By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046…

Why was Docetaxel Injection USP recalled?

Defective Container: complaint for seal and cap vial issues that could lead to a lack of sterility assurance.

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#: H7081, Exp 07/2019

Product
Docetaxel Injection USP, 80 mg/4 mL, (20 mg/mL), One-Vial Formulation, Rx only, Mfd By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046…
Recalling firm
Dr. Reddy's Laboratories, Inc.
Quantity
5,755 vials
Distribution
Nationwide in the USA
Recall date
March 20, 2019
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls