Biocompatibles Varithena injectable foam recall: Defective syringe delivery system
Biocompatibles recalls Varith: defective syringe delivery system in injectable foam product. Risk of incorrect syringe use. Check NDC 60635-123-01 and lots 476670,476669,476659,475250.
Use caution until it’s fixed
Defective Delivery System: Incorrect type of syringe found in commercially distributed administration pack
Contact the company
What happened, in plain English
Biocompatibles recalls Varithena (polidocanol injectable foam) due to a defective delivery system that may include the wrong type of syringe. This could lead to incorrect administration of the medication. Read more at govinfonow.com/recall/42453-biocompatibles-varithena-injectable-foam-recall-defective-syringe-delivery-system.
Source Summary by GovInfoNow · govinfonow.com/recall/42453-biocompatibles-varithena-injectable-foam-recall-defective-syringe-delivery-system · Updated October 9, 2026 · FDA enforcement record: FDA #D-0001-2017
Cite this page
“Biocompatibles Varithena injectable foam recall: Defective syringe delivery system.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42453-biocompatibles-varithena-injectable-foam-recall-defective-syringe-delivery-system. Based on FDA recall #D-0001-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0001-2017%22&limit=1).
Why it’s dangerous
The administration pack may contain an incorrect syringe type, which could lead to improper medication delivery. This might cause ineffective treatment or adverse reactions if the wrong syringe is used.
Who’s affected
Prescription users of Varithena injectable foam who received the recalled administration packs. Patients using the product without proper syringe checks are at higher risk.
How to tell if you have this one
Check the NDC number 60635-123-01 on the packaging. Look for lot numbers 476670, 476669, 476659, or 475250. The product expires November 2016.
- Brand
Biocompatibles- Category
Drug
What to do — step by step
Check Administration Pack
Verify the NDC number and lot numbers to confirm if your product is recalled.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Distributed nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 6 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this product safe to use?
The recall indicates a potential defect in the delivery system, so it is not safe to use without checking the recall details.
What should I do if I have the recalled product?
Check the NDC number and lot numbers to confirm if your product is recalled. Contact the manufacturer for further instructions.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0001-2017 (September 7, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0001-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 9, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.