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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

H J Harkins Company Inc dba Pharma Pac: Losartan Potassium 100 mg Tablets Recalled for NMBA Impurity

Agency Publication Date: April 7, 2019
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Summary

Approximately 300 tablets of Losartan Potassium (100 mg), a blood pressure medication, are being recalled because trace amounts of an impurity called N-Nitroso N-Methyl 4-amino butyric acid (NMBA) were found in the active ingredient. The affected products are white to off-white, tear-drop shaped tablets debossed with "H" on one side and "145" on the other, sold in 30-count bottles. These tablets were distributed to a physician's office in California.

Risk

The recall is due to the presence of NMBA, which is classified as a potential human carcinogen. While no injuries have been reported, long-term exposure to this impurity above acceptable levels may increase the risk of cancer.

What You Should Do

  1. Check your medication bottle for Losartan Potassium 100 mg Tablets with Pharma Pac NDC 76519-1033-03 and Pharma Pac Lot # LTO00EW (Exp. 11/19).
  2. Verify if the manufacturer details on the bottle include MFG NDC 31722-0702-30 and MFG Lot # LOP17087 (Exp. 11/2019).
  3. Do not stop taking your medication immediately. For patients taking recalled Losartan, the risk of stopping your blood pressure medication suddenly may be greater than the risk posed by the impurity.
  4. Contact your healthcare provider or pharmacist right away to discuss your treatment options and obtain a replacement or alternative medication.
  5. Return any unused tablets to your pharmacy for a refund and contact H J Harkins Company Inc dba Pharma Pac at 1400 W Grand Ave Ste F, Grover Beach, CA 93433-4221 for further instructions.
  6. For additional questions or to report a side effect, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

💰Full 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: Losartan Potassium 100 mg Tablets (30 count)
Model:
Pharma Pac NDC: 76519-1033-03
MFG NDC 31722-0702-30
Lot Numbers:
LTO00EW (Exp. 11/19)
LOP17087 (Exp. 11/2019)
Date Ranges: Exp. 11/19, Exp. 11/2019

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 82574
Status: Resolved
Manufacturer: H J Harkins Company Inc dba Pharma Pac
Sold By: Physician's office
Manufactured In: United States
Units Affected: 300 tablets
Distributed To: California

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.