Report of Glass Particles in Syringe Prompts Class I Recall

Mylan Institutional, a Viatris company, is recalling 22,400 syringes containing octreotide acetate injection after a customer reported glass particles in a syringe, according to the November 16, 2022, US Food and Drug Administration (FDA) Enforcement Report. The FDA designated the recall Class I, which warns use of the product could cause serious adverse health consequences or death.

“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,” stated Mylan Institutional in an October 25, 2022, announcement. “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.”

The recall affects octreotide acetate injection, 500 mcg/mL, packaged in cartons of ten 1-mL syringes (syringe NDC 67457-246-00, carton NDC 67457-246-01), from lot AJ21002 (Exp. 3/24). The lot was manufactured by Italfarmaco SpA, Italy, and was distributed throughout the United States by Mylan Institutional, Morgantown, WV, between January 11, 2022, and June 21, 2022.

Viatris voluntarily initiated the recall October 7, 2022. The FDA issued its Class I designation on November 8, 2022. As of October 25, 2022, the company said it had not received any reports of adverse reactions associated with the lot.

Octreotide acetate injection is a prescription medication used to reduce growth hormone and insulin growth factor-1 levels in patients with acromegaly. It is also used to treat symptoms associated with metastatic carcinoid tumors (flushing and diarrhea) and vasoactive intestinal peptide-secreting tumors (watery diarrhea).