FDA Announces Company-Wide Recall of All Drugs for People and Pets

A drug company is recalling all of its drugs for people and pets because it can’t assure the quality, according to a Food and Drug Administration (FDA) announcement on Wednesday. Akorn Operating Company LLC said that it filed for Chapter 7 bankruptcy earlier this year and as a result, “ceased and shutdown all operations and terminated all its employees” in the United States, the announcement said. According to the notice, the company will not be able 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,” triggering the recall. Akorn said it has not received any reports of adverse events in people or pets in connection to this recall. Akorn released a list of medications for people (pdf) and pets (pdf) that are under recall. They include a combination of codeine and acetaminophen, lorazepam, vitamin D supplements, levalbuterol, fentanyl citrate to be injected, artificial tears, a number of animal drugs, and more. “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,” said the company, adding it “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.” If you have those medications, customers are advised to throw them out and call a medical professional. Consumers with questions can contact Akorn at 800-932-5676, Monday through Friday, 9 a.m. to 6 p.m., Eastern time. If anyone has had any health-related problems from the recall or any other drug, they should contact see a medical professional. The FDA recommends consumers let it know via its MedWatch Adverse Event page or by filling out a form. Other Recent Recalls Last month, an FDA announcement said Camber Pharmaceuticals said it recalled some of its pneumonia medicine after it discovered the drug may be contaminated with the Bacillus cereus bacteria. That voluntary recall impacted one lot of Atovaquone Oral Suspension, USP in either 750-milligram or 5-milliliter doses to the consumer level due to possible contamination. The drug is meant to prevent and treat pneumonia caused by Pneumocystis jiroveci, a type of fungus that can cause infections in adults and teens who can’t tolerate other drugs. Also in March, the FDA announced a recall of Dabigatran Etcxilate Capsules at the consumer level after nitrosamine, a carcinogenic substance, was found above the “acceptable daily intake level.” The company said it hasn’t received any reports of adverse events or health problems in connection to the medication.

FDA Announces Company-Wide Recall of All Drugs for People and Pets

A drug company is recalling all of its drugs for people and pets because it can’t assure the quality, according to a Food and Drug Administration (FDA) announcement on Wednesday.

Akorn Operating Company LLC said that it filed for Chapter 7 bankruptcy earlier this year and as a result, “ceased and shutdown all operations and terminated all its employees” in the United States, the announcement said.

According to the notice, the company will not be able 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,” triggering the recall. Akorn said it has not received any reports of adverse events in people or pets in connection to this recall.

Akorn released a list of medications for people (pdf) and pets (pdf) that are under recall. They include a combination of codeine and acetaminophen, lorazepam, vitamin D supplements, levalbuterol, fentanyl citrate to be injected, artificial tears, a number of animal drugs, and more.

“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,” said the company, adding it “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.”

If you have those medications, customers are advised to throw them out and call a medical professional. Consumers with questions can contact Akorn at 800-932-5676, Monday through Friday, 9 a.m. to 6 p.m., Eastern time.

If anyone has had any health-related problems from the recall or any other drug, they should contact see a medical professional. The FDA recommends consumers let it know via its MedWatch Adverse Event page or by filling out a form.

Other Recent Recalls

Last month, an FDA announcement said Camber Pharmaceuticals said it recalled some of its pneumonia medicine after it discovered the drug may be contaminated with the Bacillus cereus bacteria. That voluntary recall impacted one lot of Atovaquone Oral Suspension, USP in either 750-milligram or 5-milliliter doses to the consumer level due to possible contamination. The drug is meant to prevent and treat pneumonia caused by Pneumocystis jiroveci, a type of fungus that can cause infections in adults and teens who can’t tolerate other drugs.

Also in March, the FDA announced a recall of Dabigatran Etcxilate Capsules at the consumer level after nitrosamine, a carcinogenic substance, was found above the “acceptable daily intake level.” The company said it hasn’t received any reports of adverse events or health problems in connection to the medication.