Viatris Inc initiated a recall of Octreotide Acetate Injection on October 7, 2022. The U.S. FDA classified this action as a Class I recall. The affected product is Octreotide Acetate Injection 500 mcg/mL, supplied in 10 x 1 mL single-dose unit-of-use syringes for subcutaneous or intravenous use. It was manufactured for Mylan Institutional LLC of Morgantown, WV, and made in Italy, under NDC numbers 67457-246-00 for the syringe and 67457-246-01 for the carton.
The reason for the recall was a product complaint describing the presence of particulate matter, specifically glass particles found in a syringe. This recall record is listed under FDA identifier D-0058-2023. According to the record, the recall status is now listed as terminated.
This report reflects only the details contained in the recall record, including the classification, the stated reason, the recalling firm, and the initiation date. No additional outcomes or safety conclusions beyond these facts are included in this report. Readers seeking general background on octreotide, including its approved uses and regulatory status, can consult the compound overview for further context.