FDA MedWatch - One Lot of Octreotide Acetate Injection, 500 mcg/mL by Mylan Institutional

Recall - Due to Glass Particulates in a Syringe

If your email program has trouble displaying this email, view as a webpage. MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: One Lot of Octreotide Acetate Injection, 500 mcg/mL by Mylan Institutional: Recall - Due to Glass Particulates in a Syringe AUDIENCE: Patient, Health Professional, Risk Manager, Endocrinology, Oncology, Pharmacy ISSUE: Mylan Institutional is recalling lot AJ21002, of Octreotide Acetate Injection, 500 mcg/mL, 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. 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. To date, no reports of adverse reactions associated with this lot have been received. For more information about this recall, click on the red button "Read Recall" below. BACKGROUND: 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. RECOMMENDATIONS: The company has 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. In addition, if you have further distributed the product, please identify your retail level customers and provide a list of customers via Microsoft Excel file to the email provided in the recall by the company within 5 business days. Sedgwick will notify your retail level customers that received the affected batches. Retailers/Users (Hospitals/Pharmacies): Immediately examine your inventory, quarantine and discontinue distribution of this lot. Wholesalers and retailers (hospitals/pharmacies) please proceed to items listed below: Immediately examine your inventory, quarantine, and discontinue distribution of this lot. Carry out a physical count and record this data on the Business Reply Card and Packing Slip which are included. Mail the postage paid Business Reply Card to the address provided. Return the recalled product with the Packing Slip using the prepaid UPS Return Service shipping labels to the company. Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178. Follow us on Twitter at @FDAMedWatch

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