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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Qualgen, LLC: Estradiol and Testosterone Pellets Recalled for Labeling Errors

Agency Publication Date: June 29, 2018
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Summary

Qualgen, LLC is recalling approximately 2,940 units of Estradiol (20mg) and Testosterone (200mg) pellets packaged in 1-count 3ml amber vials. These compounded medications were distributed nationwide and are being recalled because they have incorrect or missing lot numbers and expiration dates on their labels. Labeling errors like these can prevent patients and healthcare providers from knowing if a drug is expired or being able to identify specific batches in the event of a safety concern. No injuries have been reported in connection with this recall.

Risk

Missing or incorrect expiration dates may lead to the use of medication that has lost its potency or safety over time. Without accurate lot numbers, it is also difficult for consumers to identify if their specific medication is part of a batch affected by quality or safety issues.

What You Should Do

  1. Check your medication packaging for Estradiol 20mg Pellets (NDC 69761-020-01) with lot numbers C211 (Exp. 10/03/2018), C257 (Exp. 12/14/2018), or D001 (Exp. 01/02/19).
  2. Check your medication packaging for Testosterone 200mg Pellets (NDC 69761-120-01) with lot number D001 (EXP: 01/02/2018 CPD: 01/02/2019).
  3. Contact your healthcare provider or pharmacist immediately for guidance if you identify that you have an affected product.
  4. Return any unused pellets to the pharmacy or place of purchase for a refund and contact Qualgen, LLC at their Edmond, Oklahoma location for further instructions.
  5. If you have additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Healthcare provider consultation and pharmacy refund.

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

Affected Products

Product: ESTRADIOL 20mg PELLET (1-count 3ml amber vial)
Model:
NDC 69761-020-01
Recall #: D-0892-2018
Lot Numbers:
C211 (Exp. 10/03/2018)
C257 (Exp. 12/14/2018)
D001 (Exp. 01/02/19)
Date Ranges: 10/03/2018, 12/14/2018, 01/02/2019
Product: TESTOSTERONE 200 mg PELLET (1-count 3ml amber vial)
Model:
NDC 69761-120-01
Recall #: D-0893-2018
Lot Numbers:
D001 (EXP: 01/02/2018 CPD: 01/02/2019)
Date Ranges: 01/02/2018, 01/02/2019

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 80203
Status: Resolved
Manufacturer: Qualgen, LLC
Sold By: Qualgen, LLC
Manufactured In: United States
Units Affected: 2,940 pellets
Distributed To: Nationwide

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 ยท 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.