Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Defective Delivery System: Incorrect type of syringe found in commercially distributed administration pack
Cause type: Packaging defect
Failed child-resistant closures, leaks, cracked containers, or a defective delivery device. Packaging failures risk accidental exposure (especially to children) or product contamination. All packaging defect recalls.
Varithena (polidocanol injectable foam) Administration Pack For Use With Varithena, Rx only, Distributed by Biocompatibles, Inc. Oxford, CT 06478, NDC 60635-123-01
Compare with the code on your package — it is the most precise check available.
Drug: Polidocanol
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
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).
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Defective Delivery System: out of specification result for droplet size distribution at the d90 measurement testing during the 6 month time point..
Defective delivery system: detached needles on the syringe in the kit.
Defective Delivery System; reports of damaged product that may alter the predicted release of scopolamine following transdermal application.
Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the z-statistic values.
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