Medications & Supplements/Prescription Drugs

Dr. Reddy's Laboratories, Inc.: Docetaxel Injection Recalled Due to Defective Vial Seals

Agency Publication Date: January 11, 2018

Summary

Dr. Reddy's Laboratories is recalling 1,051 vials of Docetaxel Injection USP (20 mg/mL) because of a defect in the vial's container seal. In some cases, flipping off the protective cap may accidentally remove the entire aluminum seal or the stopper, which can compromise the sterility of the medication. This recall affects one-vial formulations manufactured by Dr. Reddy's Laboratories Limited in India and distributed across the United States.

Risk

A compromised seal or dislodged stopper can expose the sterile medication to the environment, leading to potential contamination. Using a contaminated injectable drug poses a serious risk of infection or other complications for patients receiving this treatment.

What You Should Do

Check your medication supply for Docetaxel Injection USP, 20 mg/mL, One-Vial Formulation with NDC 43598-611-11.
Locate the lot number on the vial or packaging to see if it matches Lot H7044 with an expiration date of 05/19.
If you identify an affected vial, do not use it; contact your healthcare provider or pharmacist immediately for guidance on alternatives and to report the issue.
Return any unused product from the affected lot to the pharmacy where it was purchased for a refund.
Contact Dr. Reddy's Laboratories, Inc. at their Princeton, NJ location for further instructions regarding the return process.
For additional questions or to report safety concerns, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Pharmacy return for 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, 20 mg/mL, One-Vial Formulation

Model:

NDC 43598-611-11

Recall #: D-0213-2018

Lot Numbers:

H7044 (Exp 05/19)

Date Ranges: Expiration date 05/19

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 78842

Status: Resolved

Manufacturer: Dr. Reddy's Laboratories, Inc.

Sold By: Hospitals; Clinics; Pharmacies

Manufactured In: India, United States

Units Affected: 1,051 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 supply for Docetaxel Injection USP, 20 mg/mL, One-Vial Formulation with NDC 43598-611-11.

Locate the lot number on the vial or packaging to see if it matches Lot H7044 with an expiration date of 05/19.

If you identify an affected vial, do not use it; contact your healthcare provider or pharmacist immediately for guidance on alternatives and to report the issue.

Return any unused product from the affected lot to the pharmacy where it was purchased for a refund.

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

For additional questions or to report safety concerns, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.