Section
Recalls
Enforcement reports: what was recalled, by whom, how much of it, where it went and the reason the record gives.
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Lupin recalls liraglutide pen injectors after particulate found in a cartridge
The nationwide Class II recall covers 217,621 pen injectors. The enforcement record gives the reason as presence of particulate matter, described as a white thread-like structure in the cartridge.
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ProRx recalls two compounded semaglutide presentations over sterility assurance
Two firm-initiated Class II recalls cover 8,400 vials of one multidose presentation and 8,310 of another, distributed in Texas and Utah.
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Aequita Pharmacy recalls compounded vials over processing controls
A Class II recall covering 190 multidose vials distributed in Massachusetts gives the reason as lack of processing controls.
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Thrive Health Solutions recalls three compounded syringe presentations
Three Class II recalls initiated on the same day cover pre-filled syringes of semaglutide, of tirzepatide, and of a tirzepatide and cyanocobalamin combination.
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ProRx tirzepatide recall from 2024 is still recorded as ongoing
A Class II recall of 37 compounded multidose vials, initiated in August 2024 and classified that September, carries the status ongoing in the enforcement file.
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Tailor Made Compounding recall from 2022 remains open on the enforcement file
The Class II recall covers 9,993 vials distributed nationwide and in Puerto Rico, and is still recorded with the status ongoing.
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Novo Nordisk sample recall over storage temperature is recorded as terminated
The 2021 Class II recall of liraglutide sample pens, initiated over storage below the required temperature, carries the status terminated in the enforcement file.