Glass in a Vial Leads to Recall of One Lot of Octreotide

Mylan Institutional, a Viatris company, is voluntarily recalling one lot of Octreotide Acetate Injection 500 mcg/mL. This lot is being recalled because of product complaint of the presence of glass particles in a syringe. Intravenous administration of a solution containing particulate matter, such as a glass, could lead to events including local irritation or swelling, vasculitis/phlebitis, antigenic or allergic reactions, and microvascular obstruction, including pulmonary embolism. To date, no reports of adverse reactions associated with this lot have been received.

Octreotide Acetate Injection is indicated to reduce blood levels of growth hormone and insulin growth factor-1 in patients with acromegaly, a rare condition where the body produces too much growth hormone. It is also indicated for the symptomatic treatment of patients with metastatic carcinoid tumors because it suppresses the severe diarrhea and flushing episodes associated with the disease.

The lot, AJ21002 with the expiration date of March 2024, was manufactured by Italfarmaco in Italy and was distributed by Mylan in the United States between January 11 and June 21, 2022. It was packaged in a carton of 10 1mL syringes. The NDC numbers of the affected lot are 67457-246-00 (syringe) and 67457-246-01 (carton).