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.
Recommendations
- On June 27, 2020, Fresh Express recalled products containing either iceberg lettuce, red cabbage or carrots and displaying the product code Z178, or a lower number. The “Best by” date on the products run through July 14, 2020. The product code is located in the upper right-hand corner of the front of each package. Consumers should not eat, and restaurants and retailers should not sell or serve any of the recalled products. These products may either be branded with the Fresh Express label, or they may be branded with a number of retail store brand labels.
- The recalled retail store brands are ALDI Little Salad Bar, Giant Eagle, Hy-Vee, Jewel-Osco Signature Farms, ShopRite Wholesome Pantry, and Walmart Marketside.
- The recalled products displaying the product code Z178 or lower were sold in Arkansas, Connecticut, Delaware, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Dakota, Tennessee, Virginia, Vermont, Wisconsin, West Virginia, and the District of Columbia.
- The recalled products were made in the Fresh Express production facility in Streamwood, Illinois and have the potential to be contaminated with Cyclospora. The recent Fresh Express recall also includes previously recalled store brands.
Investigation Update
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.
