Medications & Supplements/Prescription Drugs

Sanofi-Aventis U.S. LLC: Admelog Insulin Pens Recalled Due to Potential Temperature Exposure

Agency Publication Date: July 10, 2018

Summary

Sanofi-Aventis U.S. LLC is recalling 3,214 units of Admelog Solostar (insulin lispro injection) 100 units/mL prefilled pens. These specific units were distributed as physician samples and may not have been shipped at the required temperature, which can affect the medication's potency and safety. Consumers should check their pens for lot number 7F021B with an expiration date of June 30, 2020.

Risk

Insulin is a temperature-sensitive medication; exposure to improper temperatures (temperature abuse) during shipping can cause the insulin to lose its effectiveness. If a patient uses compromised insulin, they may not receive the intended dose, leading to high blood sugar levels (hyperglycemia) and potentially serious health complications.

What You Should Do

Check your Admelog Solostar (insulin lispro injection) 3mL prefilled pen box for NDC 0024-5925-00 and Lot Number 7F021B with an expiration date of 6/30/20.
Immediately contact your healthcare provider or pharmacist if you determine you have a physician sample from this affected lot to discuss alternative treatment options.
Do not use the affected insulin if you have not already done so; return any unused prefilled pens from this lot to the physician's office or pharmacy where they were received for a refund or replacement.
Contact Sanofi-Aventis U.S. LLC at their Bridgewater, New Jersey headquarters or through your healthcare provider for further instructions regarding this voluntary recall.
For additional questions or to report a problem, 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

Healthcare provider consultation and product return.

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

Affected Products

Product: Admelog Solostar (insulin lispro injection) 100 units/mL (U-100) (3mL)

Model:

NDC 0024-5925-00

Lot Numbers:

7F021B (Exp 6/30/20)

Date Ranges: Expiration Date 6/30/20

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80387

Status: Active

Manufacturer: Sanofi-Aventis U.S. LLC

Sold By: Physician Offices; Medical Samples

Manufactured In: United States

Units Affected: 3214 prefilled pens

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 Admelog Solostar (insulin lispro injection) 3mL prefilled pen box for NDC 0024-5925-00 and Lot Number 7F021B with an expiration date of 6/30/20.

Immediately contact your healthcare provider or pharmacist if you determine you have a physician sample from this affected lot to discuss alternative treatment options.

Do not use the affected insulin if you have not already done so; return any unused prefilled pens from this lot to the physician's office or pharmacy where they were received for a refund or replacement.

Contact Sanofi-Aventis U.S. LLC at their Bridgewater, New Jersey headquarters or through your healthcare provider for further instructions regarding this voluntary recall.

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