Sweden health authority warns on falsified exenatide pens
Reported from the analysis, not from a warning notice.
TheCompound Journal
Reporting on incretins, compounding & the peptide supply chain
The Supply Chain Dispatch
Reported from the analysis, not from a warning notice.
The health authority in Poland has issued a warning on falsified semaglutide injection pens found in the legitimate supply chain. The Journal has reviewed the notice and the accompanying photographs; the distinguishing features are a batch-number font difference and a needle-shield colour, neither of which a patient could reasonably be expected to detect.
Comparison of 11 certificates supplied by the reseller against the laboratory’s public archive matched 7 of them to reports commissioned by other parties, in some cases more than a year earlier. The reseller did not respond to two written requests for comment.
Comparison of 11 certificates supplied by the reseller against the laboratory’s public archive matched 7 of them to reports commissioned by other parties, in some cases more than a year earlier. The reseller did not respond to two written requests for comment.
The document is the weakest link in this trade. A certificate is a PDF; a laboratory letterhead is an image; a lot number is a string. Nothing in the ordinary transaction allows a buyer to confirm that a given report was issued for a given vial, and the four independent services differ in whether they offer any lookup at all.
Yusuf Kandemir, freight and customs broker, Istanbul, said the underfill finding was the more consequential one. "Nobody is being poisoned by a low content figure. Everybody using that vial is out by a fifth in every calculation they make."
The Journal has referred the cloned document to the laboratory named on it and has asked all four independent services whether they will offer a public report-number lookup. Two have replied.
Reported from the analysis, not from a warning notice.
An isoaspartate rearrangement changes the molecule and not the mass. A method that confirms identity by molecular weight alone will report it as the parent compound.
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
Two signatures — one who performed the work, one who approved its release — are the ordinary regulated convention and are almost unknown here.
Purity, content, identity, sterility and endotoxin are five separate determinations. A single sheet of paper carrying one of them is not evidence about the other four.
Reported from the analysis, not from a warning notice.