Medications & Supplements/Prescription Drugs

Genentech, Inc.: Activase (alteplase) Recalled for Potential Glass Contamination

Agency Publication Date: December 4, 2017

Summary

Genentech, Inc. is recalling approximately 16,882 units of Activase (alteplase) 100 mg lyophilized vials because the sterile water for injection included in the kit may contain cracked or chipped glass at the neck of the vial. This defect was found in kits sold nationwide with specific lot numbers and expiration dates through 2019. Consumers should not use the affected sterile water as it poses a serious risk of non-sterility and glass contamination.

Risk

The presence of cracked or chipped glass can compromise the sterility of the water used to prepare the medication and may lead to glass fragments being injected into a patient. This can cause serious health complications, including local irritation, inflammation, or more severe systemic infections and vascular damage.

What You Should Do

Check your supply for Activase (alteplase) 100 mg kits (NDC 50242-0085-27) with the following lot numbers: 3128243 (Exp. 9/30/2018), 3141239 (Exp. 9/30/2018), or 3166728 (Exp. 2/28/2019).
Inspect the neck of the 100ml sterile water for injection vial included in these kits for any signs of cracked or chipped glass.
Immediately stop using any kits identified with these specific lot numbers.
Contact your healthcare provider or pharmacist immediately if you have any questions or if you believe you have used a compromised kit.
Return any unused, affected product to your pharmacy or place of purchase for a refund and contact Genentech, Inc. for further instructions.
For more information or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

Full Refund

Refund or replacement instructions for drug recall

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

Affected Products

Product: Activase (alteplase), 100 mg (58 million IU), Lyophilized vial kit

Model:

NDC: 50242-0085-27

Recall #: D-1175-2017

Lot Numbers:

3128243 (Exp. 9/30/2018)

3141239 (Exp. 9/30/2018)

3166728 (Exp. 2/28/2019)

Date Ranges: Exp. 9/30/2018, Exp. 2/28/2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 78088

Status: Resolved

Manufacturer: Genentech, Inc.

Sold By: pharmacies; hospitals

Manufactured In: United States

Units Affected: 16,882

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

Risk

What You Should Do

Check your supply for Activase (alteplase) 100 mg kits (NDC 50242-0085-27) with the following lot numbers: 3128243 (Exp. 9/30/2018), 3141239 (Exp. 9/30/2018), or 3166728 (Exp. 2/28/2019).

Inspect the neck of the 100ml sterile water for injection vial included in these kits for any signs of cracked or chipped glass.

Immediately stop using any kits identified with these specific lot numbers.

Contact your healthcare provider or pharmacist immediately if you have any questions or if you believe you have used a compromised kit.

Return any unused, affected product to your pharmacy or place of purchase for a refund and contact Genentech, Inc. for further instructions.

For more information or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).