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| The United States: Mylan initiates voluntary nationwide recall of one lot of Daptomycin for Injection, due to the presence of particulate (English only) |
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The US Food and Drug Administration (FDA) announces that Mylan Institutional LLC is conducting a voluntary nationwide recall to the consumer level of one lot of Daptomycin for Injection, 500 mg/vial (lot number: 7605112) due to the presence of particulate matter found in one single-dose vial manufactured by Mylan Laboratories Limited’s Specialty Formulation Facility. To date, Mylan has not received any reports of adverse events related to this recall.
Intravenous administration of a solution containing visible particulates could lead to serious adverse events including, but not limited to, local irritation, vasculitis/phlebitis, antigenic or allergic reactions, and microvascular obstruction, including pulmonary embolism.
This batch was distributed nationwide to wholesalers and retail pharmacies between April 2020 and May 2020.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mylan-initiates-voluntary-nationwide-recall-one-lot-daptomycin-injection-due-presence-particulate
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Wednesday, Jul 8, 2020
Issued at HKT 15:00
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