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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

Biocompatibles U.K., Ltd.: Varithena Administration Packs Recalled Due to Incorrect Syringe Type

Agency Publication Date: November 2, 2018
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Summary

Biocompatibles U.K., Ltd. has recalled approximately 3,254 Varithena (polidocanol injectable foam) Administration Packs because they may contain an incorrect type of syringe. These packs are used specifically for the administration of Varithena, a prescription medication for vein treatment. The defect involves a delivery system failure where the syringe provided in the commercially distributed pack does not match the required specifications for use. Consumers who have these packs should contact their healthcare provider or pharmacist, as the product was distributed nationwide with expiration dates of November 2016.

Risk

The inclusion of an incorrect syringe in the administration kit may lead to difficulties or failure in properly delivering the injectable foam medication. This defect could potentially impact the effectiveness of the treatment or cause complications during the medical procedure.

What You Should Do

  1. Check your Varithena Administration Pack for NDC 60635-123-01 to see if it is part of this recall.
  2. Verify the lot number on the packaging; the affected lot numbers are 476670, 476669, 476659, and 475250.
  3. Confirm if the expiration date is November 2016 (Exp 11/16).
  4. If your pack is affected, do not use the administration components and contact your healthcare provider or pharmacist immediately for guidance.
  5. Return any unused administration packs to the pharmacy or place of purchase for a refund.
  6. Contact the manufacturer, Biocompatibles U.K., Ltd., or the distributor, Biocompatibles, Inc., for further instructions on returning defective kits.
  7. For 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: Varithena (polidocanol injectable foam) Administration Pack
Model:
NDC 60635-123-01
Lot Numbers:
476670 (Exp 11/16)
476669 (Exp 11/16)
476659 (Exp 11/16)
475250 (Exp 11/16)
Date Ranges: Expiration 11/16

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 75253
Status: Resolved
Manufacturer: Biocompatibles U.K., Ltd.
Sold By: Biocompatibles, Inc.
Manufactured In: United Kingdom
Units Affected: 3,254 administration packs
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.