Medications & Supplements/Prescription Drugs

Tailor Made Compounding: Tesamorelin Injection Recalled for Incorrect Expiration Date Labeling

Agency Publication Date: November 2, 2018

Summary

Tailor Made Compounding is recalling approximately 10,280 vials of Tesamorelin (1mg/vial), a lyophilized powder used for subcutaneous injection. The vials were distributed with labels incorrectly indicating a one-year expiration date when the product actually has a stable shelf life of only six months. This recall affects various lots with expiration dates of July 2019 and August 2019 that were distributed nationwide throughout the United States. Consumers who have this medication should check their vial labels immediately for the affected lot numbers.

Risk

Using medication that has exceeded its six-month shelf life may lead to decreased drug potency and compromised stability. This could result in the patient receiving an ineffective dose, potentially failing to provide the intended therapeutic benefit of the treatment.

What You Should Do

Check your Tesamorelin 1mg/vial (6mL vial) packaging and vials for the following affected lot numbers and expiration dates: 7101804, 7111807, 7131807, 7151801, 7161804, 7181805, 7191801, 7201803, 7211801, 7221801, 7231805, 7241803, 7251803, 7261802, 7271801, 7281801, 7301805, 7311805 (exp 7/19); or 8021801, 8031801, 8041801, 8081802, 8091804, 8101803, 8111810, 8121801, 8141801, 8161803, 8171803, 8201801, 8251801 (exp 8/19).
Verify if the label indicates a 1-year expiration date; if so, understand that the true expiration date is 6 months earlier than what is printed on the vial.
Contact your healthcare provider or pharmacist immediately to discuss whether your medication is still effective and to determine if you need a replacement.
Return any unused or expired product to the pharmacy or place of purchase for a refund.
Contact Tailor Made Compounding at their Nicholasville, KY facility for further instructions regarding this recall.
For additional questions or to report adverse events, 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

Pharmaceutical guidance and refund

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

Affected Products

Product: Tesamorelin, 1mg/vial, 6mL vial, Lyophilized Powder for Reconstitution and Subcutaneous Injection

Model:

D-0223-2019

Lot Numbers:

7101804 (exp 7/19)

7111807 (exp 7/19)

7131807 (exp 7/19)

7151801 (exp 7/19)

7161804 (exp 7/19)

7181805 (exp 7/19)

7191801 (exp 7/19)

7201803 (exp 7/19)

7211801 (exp 7/19)

7221801 (exp 7/19)

7231805 (exp 7/19)

7241803 (exp 7/19)

7251803 (exp 7/19)

7261802 (exp 7/19)

7271801 (exp 7/19)

7281801 (exp 7/19)

7301805 (exp 7/19)

7311805 (exp 7/19)

8021801 (exp 8/19)

8031801 (exp 8/19)

8041801 (exp 8/19)

8081802 (exp 8/19)

8091804 (exp 8/19)

8101803 (exp 8/19)

8111810 (exp 8/19)

8121801 (exp 8/19)

8141801 (exp 8/19)

8161803 (exp 8/19)

8171803 (exp 8/19)

8201801 (exp 8/19)

8251801 (exp 8/19)

Date Ranges: July 2019, August 2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 81337

Status: Resolved

Manufacturer: Tailor Made Compounding

Sold By: Tailor Made Compounding

Manufactured In: United States

Units Affected: 10,280 Vials

Distributed To: Nationwide

Agency Last Updated: November 7, 2018

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 Tesamorelin 1mg/vial (6mL vial) packaging and vials for the following affected lot numbers and expiration dates: 7101804, 7111807, 7131807, 7151801, 7161804, 7181805, 7191801, 7201803, 7211801, 7221801, 7231805, 7241803, 7251803, 7261802, 7271801, 7281801, 7301805, 7311805 (exp 7/19); or 8021801, 8031801, 8041801, 8081802, 8091804, 8101803, 8111810, 8121801, 8141801, 8161803, 8171803, 8201801, 8251801 (exp 8/19).

Verify if the label indicates a 1-year expiration date; if so, understand that the true expiration date is 6 months earlier than what is printed on the vial.

Contact your healthcare provider or pharmacist immediately to discuss whether your medication is still effective and to determine if you need a replacement.

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

Contact Tailor Made Compounding at their Nicholasville, KY facility for further instructions regarding this recall.

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

Affected Products

Product: Tesamorelin, 1mg/vial, 6mL vial, Lyophilized Powder for Reconstitution and Subcutaneous Injection

Model:

D-0223-2019

Lot Numbers:

7101804 (exp 7/19)

7111807 (exp 7/19)

7131807 (exp 7/19)

7151801 (exp 7/19)

7161804 (exp 7/19)

7181805 (exp 7/19)

7191801 (exp 7/19)

7201803 (exp 7/19)

7211801 (exp 7/19)

7221801 (exp 7/19)

7231805 (exp 7/19)

7241803 (exp 7/19)

7251803 (exp 7/19)

7261802 (exp 7/19)

7271801 (exp 7/19)

7281801 (exp 7/19)

7301805 (exp 7/19)

7311805 (exp 7/19)

8021801 (exp 8/19)

8031801 (exp 8/19)

8041801 (exp 8/19)

8081802 (exp 8/19)

8091804 (exp 8/19)

8101803 (exp 8/19)

8111810 (exp 8/19)

8121801 (exp 8/19)

8141801 (exp 8/19)

8161803 (exp 8/19)

8171803 (exp 8/19)

8201801 (exp 8/19)

8251801 (exp 8/19)

Date Ranges: July 2019, August 2019