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| The United States: Mylan Institutional LLC, a Viatris Company, issues a voluntary recall of Octreotide Acetate Injection, 500 mcg／mL, due to glass particulates in a syringe (English only) |
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The US Food and Drug Administration (FDA) announces that Mylan Institutional LLC, a Viatris company, is voluntarily recalling one lot of Octreotide Acetate Injection, 500 mcg/mL, packaged in a carton of ten 1mL syringes (lot number: lot AJ21002). 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.
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.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mylan-institutional-llc-viatris-company-issues-voluntary-recall-one-lot-octreotide-acetate-injection
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Thursday, Oct 27, 2022
Issued at HKT 16:00
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