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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

LGM Pharma LLC: Cidofovir Dihydrate API Recalled for Manufacturing Deviations

Agency Publication Date: February 11, 2019
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Summary

LGM Pharma LLC is voluntarily recalling 205 grams of Cidofovir Dihydrate (non-sterile), a drug ingredient used for manufacturing. The recall was initiated because the manufacturer of the Active Pharmaceutical Ingredient (API), ALP PHARM BEIJING CO., LTD, is currently on an FDA Import Alert. This means the facility did not meet Current Good Manufacturing Practice (CGMP) standards, which are required to ensure the quality, strength, and purity of drugs.

Risk

The use of drug ingredients from a manufacturer on FDA Import Alert suggests a breakdown in quality control, which could lead to products that are contaminated or do not meet safety specifications. While this specific ingredient is intended for manufacturing use rather than direct consumer consumption, products made with it could pose health risks to patients.

What You Should Do

  1. Locate any containers of Cidofovir Dihydrate (Non-Sterile, For Manufacturing Use) in 10g sizes to check for affected batch and lot numbers.
  2. Verify if your product matches Batch Number JD-BP-37-20150801 or Lot Number JD-BP-37-20150801 from ALP PHARM BEIJING CO., LTD.
  3. If you are a manufacturer using this ingredient, stop using the affected lot immediately and quarantine any remaining stock.
  4. Contact your healthcare provider or pharmacist for guidance if you believe you have received a finished medication prepared using this specific batch of Cidofovir Dihydrate.
  5. Return any unused product to LGM Pharma LLC or your point of purchase for a refund and contact the manufacturer for further instructions regarding the disposal or return of the chemical.
  6. Contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

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: CIDOFOVIR DIHYDRATE, (Non-Sterile, For Manufacturing Use), 10g
Lot Numbers:
JD-BP-37-20150801

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 81790
Status: Resolved
Manufacturer: LGM Pharma LLC
Manufactured In: United States, China
Units Affected: 205 grams
Distributed To: Mississippi

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.