Why it was recalled
Defective Delivery System: incorrect silicone oil-free NormJect 10 mL Luer Lock Solo syringes packaged in the pack, instead of the required silicone oil-free NormJect 10 mL Luer Solo syringes (luer slip connection).
Product description
Varithena (polidocanol injectable foam) Administration Pack, Contains: 3 silicone-free syringes, 2 compression pads, 1 Varithena Transfer Unit, 1 manometer tubing, Rx Only, Distributed by Biocompatibles Inc., a BTG International Group company. CN01114.3
Lot numbers, UPCs & expiration codes
Lot # 34067418, Exp. March 2026, 34067419, Exp. March 2026
Where it was sold
Nationwide in the USA.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0113-2025
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Aug 15, 2024
- FDA report date
- Dec 18, 2024
- Quantity
- 432 administration packs
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Biocompatibles UK, Ltd.
Original FDA data
Every field from FDA enforcement report D-0113-2025, exactly as published.
Show all FDA fields
- City
- Farnham
- Status
- Terminated
- Country
- United Kingdom
- Event ID
- 95820
- Address
- Chapman House
- Address (line 2)
- Farnham Business Park; Weydon Lane
- Code information
- Lot # 34067418, Exp. March 2026, 34067419, Exp. March 2026
- Report date
- Dec 18, 2024
- Product type
- Drugs
- Recall number
- D-0113-2025
- Classification
- Class III
- Recalling firm
- Biocompatibles UK, Ltd.
- Product quantity
- 432 administration packs
- Termination date
- Feb 21, 2025
- Reason for recall
- Defective Delivery System: incorrect silicone oil-free NormJect 10 mL Luer Lock Solo syringes packaged in the pack, instead of the required silicone oil-free NormJect 10 mL Luer Solo syringes (luer slip connection).
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Varithena (polidocanol injectable foam) Administration Pack, Contains: 3 silicone-free syringes, 2 compression pads, 1 Varithena Transfer Unit, 1 manometer tubing, Rx Only, Distributed by Biocompatibles Inc., a BTG International Group company. CN01114.3
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Aug 15, 2024
- Initial firm notification
- Letter
- Center classification date
- Dec 6, 2024