United States
Mylan Institutional LLC, a Viatris company, is voluntarily recalling lot AJ21002, exp 3/2024, of Octreotide Acetate Injection, 500 mcg/mL, packaged in a carton of ten 1mL syringes. This lot is being recalled at the user (hospital/pharmacy) level due to a product complaint of the presence of glass particles in a syringe. This lot was manufactured by Italfarmaco SpA, Italy and was distributed by Mylan Institutional LLC in the US between January 11 and June 21, 2022. To date, no reports of adverse reactions associated with this lot have been received.
The recalled lot is as follows:
NDC #: 67457-246-00 (Syringe); 67457-246-01 (Carton), Name and Strength: Octreotide Acetate Injection 500 mcg/mL, Size: 10 X 1 mL Single dose unit-of-use Syringe. Lot#: AJ21002, Expiry: March 2024
Intravenous administration of a solution containing particulate matter, such as a glass, could lead to events including, but not limited to, local irritation or swelling, vasculitis/phlebitis, antigenic or allergic reactions, and microvascular obstruction, including pulmonary embolism. Although the intravenous administration of a solution containing particulate matter may pose potential risk of serious adverse events, the probability of exposure from this incident and subsequent risk is low.
Octreotide Acetate Injection is indicated to reduce blood levels of growth hormone (GH) and insulin growth factor-1 (IGF-1; somatomedin C) 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 company has initiated the recall of lot AJ21002 and notified its distributors by letter/phone and is arranging for return of all recalled products. Following are actions for wholesalers and retailers/users (hospitals/pharmacies):
Wholesalers: Immediately examine your inventory, quarantine and discontinue distribution of this lot.
Retailers/Users (Hospitals/Pharmacies): Immediately examine your inventory, quarantine and discontinue distribution of this lot.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
In case you experienced harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance.
Company name: Mylan Institutional LLC, a Viatris company
Brand name: Mylan Institutional LLC
Product recalled: Octreotide Acetate Injection, 500 mcg/mL
Reason of the recall: Due to glass particulates
FDA Recall date: October 25, 2022
Source:
www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mylan-institutional-llc-viatris-company-issues-voluntary-recall-one-lot-octreotide-acetate-injection
