Plus   Neg

FDA Issues Warning Letter To Drug Distributor McKesson

The Food and Drug Administration Tuesday said it has sent a warning letter to drug distributor McKessson for allegedly shipping "illegitimate" opioid products.

FDA sent its first warning letter under the Drug Supply Chain Security Act to McKesson Corp. for violations highlighted by a concerning tampering incident that involved opioid medications.

Other incidents involved medications for serious medical conditions including HIV, seizures, bipolar disorder and high blood pressure.

Under the DSCSA, manufacturers, repackagers, wholesale distributors and dispensers - which are mainly pharmacies - are all required to have systems and processes in place to quarantine and investigate suspect and illegitimate medications. These systems must be in place in order to respond rapidly to notifications of illegitimate products and to notify trading partners and the FDA when illegitimate products are discovered.

The warning letter to McKesson outlines violations observed during inspections that took place this past summer, including failing to: sufficiently respond to notifications that there was illegitimate product in their supply chain; quarantine and investigate suspect products; and maintain records of investigations of suspect product and disposition of illegitimate product as the law requires.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
The U.S. Food and Drug Administration or FDA announced on its website that pharma major Pfizer, Inc. issued recall of two lots of tablets meant to treat acute migraine in adults for concerns over bacteria infection. The pharma company is recalling two lots of Relpax (eletriptan hydrobromide) 40 mg tablets for potential presence of Genus Pseudomonas and Burkholderia bacteria. Cosmetics company Revlon Inc. (REV) is reportedly considering a potential sale of parts or all of its business. According to Bloomberg, Revlon has retained financial advisers from Goldman Sachs Group Inc. to explore strategic alternatives. No deal has been reached yet, but Revlon is exploring all... China's Lenovo Group Ltd. warned it may have to raise prices of its products if the U.S. moves ahead with the decision to impose additional tariffs on Chinese goods, according to a report by Reuters. The warning by Lenovo, the world's largest PC maker, comes amid the escalating trade war between the U.S. and China that has raised concerns about the global economic outlook.
Follow RTT