Mylan Pharmaceuticals also announced that a batch of daptomycin has been recalled due to contamination.
Mylan Issues Recall of Single Daptomycin Lot
Mylan N.V.External Link Disclaimer (NASDAQ: MYL) today announced that its U.S.-based Mylan Institutional LLC business is conducting a voluntary nationwide recall to the consumer level of one lot of Daptomycin for Injection, 500 mg/vial 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.
Read the full recall statement.
Cyclospora Investigation Linked to FreshExpress Salad Continues
The FDA, along with CDC and state and local partners continue to investigate a multistate outbreak of Cyclospora infections potentially linked to salad products that were made by Fresh Express containing iceberg lettuce, red cabbage, and carrots and that were sold in several regions of the United States. The investigation includes Fresh Express branded products as well as products made by Fresh Express for retail store brands sold at ALDI, Giant Eagle, Hy-Vee, Jewel-Osco, ShopRite, and Walmart. Investigators continue to look into whether other retail brands may be impacted.
July 9, 2020
FDA’s traceback investigation is ongoing to determine the cause and source of the outbreak. Salad ingredients (iceberg lettuce, carrots, red cabbage) continue to be items of interest in the investigation. FDA’s inspection continues at the Fresh Express production facility in Streamwood, Illinois.
As of July 8, 2020, CDC is reporting a total of 509 cases across 8 states.
The Public Health Agency of Canada has issued a public health notice regarding an outbreak of Cyclospora infections in Canada. Exposure to certain Fresh Express brand salad products containing iceberg lettuce, carrots, and red cabbage, has been identified as a likely source of the outbreak. The Public Health Agency of Canada, Canadian Food Inspection Agency, FDA and CDC are collaborating on these ongoing Cyclospora investigations.
FDA continues to work with retailers to ensure the potentially adulterated products are effectively removed from the marketplace. As this outbreak investigation continues, the FDA will provide additional updates to this advisory.
Read the full announcement page here.