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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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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Duren Health Mart Pharmacy: Various Compounded Medications Recalled for Lack of Processing Controls

Agency Publication Date: January 28, 2019
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Summary

Duren Health Mart Pharmacy has recalled approximately 6,222 units of various compounded medications, including Omeprazole suspension, Progesterone and Testosterone creams, and Promethazine gel, due to a lack of processing controls during manufacturing. These prescription medications were produced without sufficient quality oversight, which can lead to inconsistencies in the drug's potency or safety. The affected products were distributed exclusively in Tennessee between 2018 and 2019.

Risk

A lack of processing controls means the pharmacy cannot guarantee the strength, quality, or purity of the medication. This poses a risk that a patient may receive too much or too little of the active ingredient, or a contaminated product, which could lead to ineffective treatment or adverse health reactions.

What You Should Do

  1. Check your medication labels for 'Duren's Health Mart Pharmacy' and the following NDC numbers: Omeprazole (NDC 00000-0001-07), Progesterone cream (NDC 00000-0002-99), Testosterone cream (NDC 00000-0000-98), Promethazine Gel (NDC 00002-1901-03), Progesterone capsules (NDC 00311-2003-01), or Domperidone (NDC 00507-2011-00).
  2. Confirm if your prescription matches the recalled quantities: Omeprazole (150cc to 300cc), Progesterone cream (12gm to 30gm), Testosterone cream (30g), Promethazine Gel (1cc to 10cc), Progesterone capsules (30-180 count), or Domperidone (100-count).
  3. Contact your healthcare provider or pharmacist immediately to discuss alternative medications and to determine if your current supply is safe to use.
  4. Return any unused portion of the recalled medication to Duren Health Mart Pharmacy at 215 Dexter Woods Blvd., Waynesboro, TN 38485 for a refund and proper disposal.
  5. For more information or to report a problem, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Contact healthcare provider and return product.

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

Affected Products

Product: Omeprazole 4 mg/mL Suspension (150cc to 300 cc)
Model:
NDC 00000-0001-07
Product: Progesterone 10% cream (12gm to 30gm)
Model:
NDC 00000-0002-99
Product: Testosterone 0.1% cream (30 grams)
Model:
NDC 00000-0000-98
Product: Promethazine Gel 50 mg/mL (1cc to 10cc)
Model:
NDC 00002-1901-03
Product: Progesterone 100 mg SR capsules (30-180 capsules)
Model:
NDC 00311-2003-01
Product: Domperidone 10 mg capsules (100-count)
Model:
NDC 00507-2011-00

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 81811
Status: Resolved
Manufacturer: Duren Health Mart Pharmacy
Sold By: Duren Health Mart Pharmacy
Manufactured In: United States
Units Affected: 6 products (2700 cc; 200 grams; 300 grams; 876 cc; 1306 capsules; 840 capsules)
Distributed To: Tennessee

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 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.