Mylan Institutional LLC, a Viatris Company, has voluntarily recalled 1 lot of Octreotide Acetate Injection, 500mcg/mL due to a product complaint of the presence of glass particles in a syringe.
Octreotide Acetate Injection is indicated to reduce blood levels of growth hormone and insulin growth factor-1 in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses. It is also indicated for the symptomatic treatment of patients with metastatic carcinoid tumors where it suppresses or inhibits the severe diarrhea and flushing episodes associated with the disease and for the treatment of the profuse watery diarrhea associated with vasoactive intestinal peptide (VIP)-secreting tumors.
The recalled lot of Octreotide Acetate Injection, 500mcg/mL; NDC # 67457-246-00 (Syringe), 67457-246-01 (Carton); Size 10 x 1mL single-dose unit-of-use syringe; Lot # AJ21002; Expiration Date March 2024, was distributed to wholesalers, retailers/users (hospitals/pharmacies), and distributors in the US between January 11, 2022 and June 21, 2022. This lot was manufactured by Italfarmaco SpA, Italy.
According to the Company, the administration of recalled products may lead to events including, but not limited to, local irritation or swelling, vasculitis/phlebitis, antigenic or allergic reactions, and microvascular obstruction, including pulmonary embolism. To date, the Company has not received any reports of adverse reactions related to this recall.
Adverse reactions or quality problems should be reported to the Food and Drug Administration’s MedWatch program.
Mylan Institutional LLC, a Viatris Company, issues a voluntary recall of one lot of Octreotide Acetate Injection, 500 mcg/mL, due to glass particulates in a syringe. News release. Mylan Institutional LLC, a Viatris Company. October 25, 2022. Accessed October 26, 2022. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mylan-institutional-llc-viatris-company-issues-voluntary-recall-one-lot-octreotide-acetate-injection