Medications & Supplements/Prescription Drugs

Dr. Reddy's Laboratories, Inc.: Docetaxel Injection Recalled for Defective Vial Seals and Caps

Agency Publication Date: July 1, 2019

Summary

Dr. Reddy's Laboratories, Inc. is voluntarily recalling 5,755 vials of Docetaxel Injection USP (80 mg/4 mL) because the vials have defective seals and caps. This defect could compromise the sterility of the medication, potentially leading to infections or other serious complications for patients receiving the injection. This prescription drug was distributed nationwide in the USA and is used for chemotherapy treatments.

Risk

Defective seals and caps can allow microorganisms to enter the vial, which means the medication may no longer be sterile. If a non-sterile drug is injected into a patient, it can cause severe health issues, including systemic infections.

What You Should Do

Check your medication to see if it is Docetaxel Injection USP, 80 mg/4 mL (20 mg/mL), One-Vial Formulation with NDC 43598-259-40.
Verify if your product belongs to Lot H7081 with an expiration date of 07/2019.
Immediately contact your healthcare provider or pharmacist for guidance if you believe you have received or are in possession of this recalled lot.
Return any unused product to the place of purchase or the pharmacy to receive a refund.
Contact Dr. Reddy's Laboratories, Inc. at their Princeton office for further instructions regarding the return process.
Report any adverse reactions or quality problems to the FDA's MedWatch Adverse Event Reporting program either online or by calling 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

Full Refund

Healthcare provider consultation and pharmacy refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Docetaxel Injection USP, 80 mg/4 mL (20 mg/mL), One-Vial Formulation

Model:

NDC 43598-259-40

Recall #: D-1001-2019

Lot Numbers:

H7081 (Exp 07/2019)

Date Ranges: Expiration 07/2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82323

Status: Resolved

Manufacturer: Dr. Reddy's Laboratories, Inc.

Sold By: hospitals; clinics; pharmacies

Manufactured In: India, United States

Units Affected: 5,755 vials

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your medication to see if it is Docetaxel Injection USP, 80 mg/4 mL (20 mg/mL), One-Vial Formulation with NDC 43598-259-40.

Verify if your product belongs to Lot H7081 with an expiration date of 07/2019.

Immediately contact your healthcare provider or pharmacist for guidance if you believe you have received or are in possession of this recalled lot.

Return any unused product to the place of purchase or the pharmacy to receive a refund.

Contact Dr. Reddy's Laboratories, Inc. at their Princeton office for further instructions regarding the return process.

Report any adverse reactions or quality problems to the FDA's MedWatch Adverse Event Reporting program either online or by calling 1-888-723-3332 (1-888-SAFEFDA).