Biocompatibles UK, Ltd.: Drug Recall
Recall #D-0113-2025 · 08/15/2024
Class III: Low Risk
Recall Details
- Recall Number
- D-0113-2025
- Classification
- Class III
- Product Type
- Drug
- Recalling Firm
- Biocompatibles UK, Ltd.
- Status
- Terminated
- Date Initiated
- 08/15/2024
- Location
- Farnham, United Kingdom
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 432 administration packs
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).
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.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.