Medications & Supplements/Prescription Drugs

Zydus Fulvestrant Injection Recalled for Failed Impurity Specifications

Agency Publication Date: August 17, 2022

Summary

Zydus Pharmaceuticals (USA) Inc. is recalling 1,116 boxes of Fulvestrant Injection (250mg/5mL), an injectable medication used to treat certain types of breast cancer. The recall was initiated because the product failed to meet quality specifications for impurities and degradation during testing. No injuries or adverse events have been reported in connection with this recall to date.

Risk

Using medication that contains impurities or has degraded may lead to reduced effectiveness of the treatment or unexpected side effects. Because this is an injectable medication, quality failures are monitored closely to prevent potential patient harm.

What You Should Do

This recall involves Zydus Pharmaceuticals Fulvestrant Injection, 250mg/5mL (50 mg/mL), supplied in boxes containing two single-dose prefilled syringes. Affected boxes are identified by NDC 70710-1688-8 and lot number B200076 with an expiration date of January 31, 2024.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Fulvestrant Injection 250mg/5mL (50 mg/mL)

Variants: 2 Single-Dose Prefilled Syringes, Product of India, Rx Only

Lot Numbers:

B200076 (Exp 31 JAN 2024)

NDC:

70710-1688-8

Quantity: 1116 boxes. Distributed by Zydus Pharmaceuticals (USA) Inc. Manufactured by Cadila Healthcare Limited.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90618

Status: Resolved

Manufacturer: Zydus Pharmaceuticals (USA) Inc

Sold By: pharmacies; hospitals

Manufactured In: India

Units Affected: 1116 boxes

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

This recall involves Zydus Pharmaceuticals Fulvestrant Injection, 250mg/5mL (50 mg/mL), supplied in boxes containing two single-dose prefilled syringes. Affected boxes are identified by NDC 70710-1688-8 and lot number B200076 with an expiration date of January 31, 2024.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.