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21 FDA, FDA warns patients and health care professionals not to use sterile products from FarmaKeio Superior Case 4:24-cv-00953-P Document 89 Filed 02/18/25 Page 28 of 32 PageID 114224 led to a recall of at least seven lots of substandard injections.22 FDA later issued a warning letter concluding that compounded drugs sold by FarmaKeio put patients at risk.23 That warning letter appears to remain open and unresolved

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Each batch released after stringent internal quality checks

Sublingual tirzepatide Sublingual formulations, including tirzepatide drops and sublingual dosing protocols , absorb through the tissue under the tongue