FOR IMMEDIATE RELEASE – April 26, 2023 – Gurnee, IL, Akorn Operating Company LLC has filed Chapter 7 bankruptcy on February 23, 2023. In connection with that filing, the company has ceased and shutdown all operations and terminated all its employees of all domestic US Sites. The Akorn Trustee is initiating a voluntary recall of various within-expiry human and animal products as a result of the closures and discontinuation of the Quality activities of these marketed products. (Refer to Attachment I and II). The discontinuation of the Quality program means the company will not be able to support or guarantee that the products will meet all intended specifications through the labeled shelf life of the product. Further distribution or use of any remaining product on the market should cease immediately.

Risk Statement: The discontinuation of the Quality program would result in the company’s inability to assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess which render the products adulterated. While specific risks to patients, from use of these adulterated products, cannot always be identified or assessed, it is also not possible to rule out patient risks resulting from the use of such products. Akorn has not received any reports of adverse events related to this recall.

The affected products are listed in Attachment I (human drugs) and II (animal drugs) of this release. The products were distributed nationwide to Wholesalers, Retailers, Manufacturers, Medical Facilities, and Repackagers and via the Internet to Consumers.

Akorn is notifying its distributors and direct consignees by direct mailing and is requesting they further notify their customers/consumers/retailers. Akorn is requesting destruction of any recalled products. Consumers/distributors/retailers that have products which are being recalled should discard and contact their doctor.

Consumers with questions regarding this recall can contact Akorn at (800) 932-5676 during normal business hours (8am – 5pm CDT) Monday – Friday. A qualified medical professional will return your call within one business day. Consumers should contact their physician, their healthcare provider or veterinarian if they, or animals in their care, have experienced any problems that may be related to taking or using these drug products.

For human drug products, adverse reactions or quality problems experienced with the use of these products may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

For animal drug products, adverse reactions or quality problems experienced with the use of animal drug products may be reported to FDA’s Center for Veterinary Medicine Adverse Event Reporting program by completing an online Form FDA 1932a available at www.fda.gov/reportanimalae.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Attachment I – List of Human Products (PDF – 241KB)

Attachment II – List of Veterinary Products (PDF – 202KB)

bookweb.com

Ratification of the Constitution by the State of Maryland, April 28, 1788. Maryland was the seventh state to do so. Maryland’s ratification message was very short and to the point. The following text is taken from the Library of Congress’s copy of Elliot’s Debates.

for more: usconstitution.net

On the heels of the January 6 insurrection, corporations like AT&T, Home Depot, Valero Energy Corp, Publix, and Walgreens pledged to suspend donations to the Sedition Caucus – the 147 GOP members of Congress who objected to the certification of the 2020 presidential election and supported Trump’s Big Lie.

However, many of those same corporations have now abandoned those pledges and resumed their financial support of the Sedition Caucus.

Over the last two years, the Sedition Caucus received over $40 million from corporate donors, some of whom previously pledged to suspend donations.

Corporations are claiming to support democracy while privately supporting pro-insurrectionists who want it destroyed. They continue to pander to consumers while donating to anti-democracy campaigns in the shadows. We see them, and we demand these corporations stop funding insurrectionists immediately.Sign and send the petition to corporations: Keep your pledge. Stop donations to pro-insurrectionist members of Congress.

Participating Organizations
Crazy Eight PAC
CREDO Mobile
Daily Kos
DemCast USA
Democracy for America Advocacy Fund
Democratic Values
Forward Blue
Future Coalition
Inequality Media Civic Action
Greenpeace
March On
OD Action
Patriotic Millionaires
People Power United
Progressive Reform Network
Real Populists
TakeItBack.Org
Voters First Victory Fund

takeitback.org

In response to a letter from 8-year-old Flint resident Mari Copeny, known as “Little Miss Flint”, President Obama announced that he will visit Flint, Michigan tomorrow to convey his support to residents affected by the city’s water crisis. The President’s visit refocuses the national spotlight on Flint, which made national headlines earlier this year after it was revealed that the Michigan state government failed to provide safe and clean drinking water to the residents of Flint for more than a year.

The crisis began in April 2014, when government officials, under pressure to cut the budget, chose to switch the city’s water source to the polluted Flint River, without adequately preventing corrosive chemicals from entering the water flow. Not long after the switch, many residents began complaining about the dirty and smelly tap water and experiencing health side effects such as hair loss and rashes – but the local government waited nearly a year before admitting to the public that there was a problem.

While Flint officials turned a blind eye, a serious public health crisis unfolded as thousands of mostly black and low-income residents and children were poisoned by elevated levels of lead in the water, which can produce a host of long term health effects including high blood pressure, memory loss, and neurological disorders. Research suggests that young children are especially vulnerable to lead exposure, as it affects children’s growth, behavior, and intelligence over time. It is estimated that between 6,000- 12,000 Flint kids have been exposed to lead, and for children, the effects of lead poisoning can be especially damaging: children with lead poisoning are seven times more likely to drop out of school and six times more likely to become involved in the juvenile justice system than those not exposed to lead. And although the availability of early intervention and education services like high-quality childcare and pre-k could help determine how well these children fare down the line, these programs are currently scarce in Flint.

The water crisis in Flint – a city in which 56 percent of the population is African American and more the 40 percent of residents live below the federal poverty line – also serves as a stark reminder of how the failures of government accountability, infrastructure investment, and environmental quality can disproportionately impact the most vulnerable communities in an area. In addition to Flint, there are cities across the country struggling with lead poisoning. For example, fourteen percent of children in Cleveland have elevated lead levels, mainly due to the persistence of lead paint in old buildings.

A recent CAP column and report illustrate how the crisis provides just one window into widespread environmental injustices faced by communities of color across the country: in fact, these communities tend to face a higher risk of exposure to lead-poisoning, water contamination, and air pollution and are more vulnerable to the impacts of climate change than whiter, more affluent communities.

As reports of the crisis began to surface earlier this year, and it became clear that the state of Michigan itself was primarily responsible for the crisis, President Obama declared a federal emergency in Flint and directed millions in federal aid to Flint, and soon after the Michigan House of Representatives approved millions more to the city. But to really solve this problem and prevent future ones, Congress, which has failed to secure any aid package for Flint, must work past gridlock to pass legislation to increase funding for water infrastructure, improve testing and monitoring, and reform regulatory oversight to make sure that no community suffers from the environmental injustices that Flint has.

BOTTOM LINE: President Obama’s trip to Flint reminds us of the troubles facing Flint and similar cities across the country. Whether it’s lead in the water, more extreme weather, or air pollution, Flint is just a particularly egregious example of the environmental injustices faced by communities of color across America. There are concrete solutions that Congress can enact to prevent problems like the ones faced by Flint, but lawmakers first have to be willing to make them.