FDA Related
FDA Labelled Essure's Birth Control Study As "Inadequate"
Following hundreds of complaints of difficulties among women who had the coils implanted, the US Food and Drug Administration (FDA) compelled Bayer to perform a post-marketing study on the negative effects of…
J&J To Pay $40.5M To NH Over Opioid Claims
Johnson & Johnson has agreed to pay $40.5 million to resolve New Hampshire's allegations over the pharmaceutical company's participation in the country's opioid epidemic,…
FDA Bans Sale Of Juul's Vaping Products
U.S. Food and Drug Administration has rejected the authorization of JUUL vaping products' sale by banning the products from the U.S. market, citing the long-term effects of…
Court Grants Temporary Stay On JUUL's Vape Products Ban
Food and Drug Administration's (FDA) order to ban the sale of JUUL's e-cigarettes has been temporarily blocked by a federal court as the manufacturer has asked for…
FDA Receives 21,000 Reports About Philips CPAP Issues
The recalled sleep apnea devices face more than 21,000 reports against it, including at least 124 deaths, claiming that the devices…
Recall of Teva Losartan Tablets Announced by FDA
The FDA has announced recall of Teva Losartan Tablets on April 27, 2019, due to the presence of cancer-causing Nitroso-N-methyl-4-aminobutyric acid (NMBA) in at least six lots of active pharmaceutical ingredient manufactured by Hetero…
FDA Recalls Fentanyl Patches Due To Dosing Errors
On April 21, the FDA announced a recall for an Alvogen Fentanyl Transdermal System over mislabeling issues in some cartons. The agency indicated that some cartons labeled as having 12 mcg/h patched were actually containing 50 mcg/h…
Losartan Recall Expanded Over Carcinogen Presence
After detecting the third cancer-causing impurity, N-Nitroso-N-methyl-4-aminobutyric acid (NMBA), the FDA and Torrent Pharmaceuticals have expanded the nationwide recall for generic losartan pills on April 18, 2019.
The…