Drug Safety Alerts

Octreotide Acetate Injection 500 mcg/mL Class I Recall

11/08/2022

On November 8, 2022, the United States Food and Drug Administration (FDA) classified the recall of one lot of Octreotide Acetate Injection 500 mcg/mL, distributed by Mylan Institutional LLC as a Class I recall. This recall was issued due to a product complaint for the presence of glass particles in a syringe. The affected lot was distributed between January 11, 2022 and June 21, 2022.

This recall affects lot number AJ21002 exp. 03/2024 of NDC’s 67457-0246-00 (Syringe) & 67457-0246-01 (Carton).

Please note: This recall was issued to the retail level on October 7, 2022. The FDA classified this a Class I recall on November 8, 2022.

According to Mylan, 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. Mylan has advised that 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. According to Mylan, as of the date of recall, no reports of adverse reactions associated with this lot have been received.

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.

CVS Caremark Response: This product is not carried by the CVS Caremark Mail Service Pharmacies.

For more information about the recall of Octreotide Acetate Injection 500 mcg/mL, please call Mylan Institutional LLC toll-free at 1-800-796-9526. You may also call the U.S. Food and Drug Administration (FDA) consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit www.accessdata.fda.gov.