The FDA has posted an ongoing Class II recall covering multiple presentations of compounded semaglutide multi-dose vials from Apollo Care, LLC, for the presence of particulate matter identified as nylon or polyamide and silk or proteinaceous-type material.
The affected presentations span the range the firm supplied — 2.5 mg, 5 mg, 6.75 mg, 7.5 mg, 9 mg, 10 mg and 20 mg vials at various concentrations, several formulated with glycine. Class II is the FDA's designation for a product where exposure may cause temporary or medically reversible harm, with serious consequences judged remote.
This concerns compounded semaglutide, not the licensed pens, and Apollo Care supplies the US market. It is carried here because compounded GLP-1 preparations move through channels that do not respect borders, and a patient presenting with an injection-site reaction on a vial-and-syringe semaglutide of uncertain provenance is a scenario an Indian clinic can meet.
- Ongoing Class II recall; particulate matter described as nylon/polyamide and silk/proteinaceous material.
- Multiple vial strengths affected, several glycine-containing.
- Compounded product from one US firm — licensed semaglutide pens are not involved.
Why it matters
Compounded GLP-1 vials are cheaper and widely sought, and a particulate contaminant is one of the few failure modes a patient cannot see coming.
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