Search results for "FDA update"
FDA update
Liva Global Inc. recalled two lots of liquid probiotics due to the possibility of contamination by Pseudomonas aeruginosa, the FDA announced on Dec.
December 2021
FDA update
One lot of senna syrup (8.8 mg in 5-mL unit-dose cups) was recalled by Lohxa LLC due to potential microbial contamination, the FDA announced on Jan. ... Recalled products were distributed to wholesaler AvKare, which may have further distributed them to
January 2022
FDA update
One lot of pantoprazole sodium for injection (40 mg per vial) was recalled from hospitals nationwide, the FDA announced on Dec.
January 2018
FDA update
On June 5, the FDA approved the first generic form of mesalamine delayed-release oral tablets USP (1.2 g).
June 2017
FDA update
Eleven lots of ranitidine tablets, USP (150 mg) were recalled by American Health Packaging due to the potential to contain excess amounts of N-nitrosodimethylamine (NDMA), a probable carcinogen, the FDA
March 2020
FDA update
cap. On Feb. 7, the FDA cleared the updated design and labeling for the Pentax Medical Duodenoscope Model ED-3490TK. ... The FDA continues to monitor the association between reprocessed endoscopes and transmission of infectious agents.
February 2018
FDA update
The FDA authorized marketing of the first fully disposable duodenoscope on Dec. ... each year, and the FDA has encouraged innovative ways to improve their safety and effectiveness, particularly with regard to cleaning and disinfecting, the agency said in
December 2019
FDA update
On April 5, the FDA issued a safety communication providing new information supporting the transition to fully disposable duodenoscopes and those with disposable components. ... Hospitals and endoscopy facilities should completely transition to
April 2022
FDA update
https://gastroenterology.acponline.org/archives/2019/09/27/8.htm. To help address abuse and misuse, the FDA approved changes to the packaging for tablet and capsule forms of the ... The FDA has approved changes to the packaging for tablet and capsule
September 2019
FDA update
The FDA announced on May 26 that it is restricting the use of obeticholic acid (Ocaliva) in patients with primary biliary cholangitis (PBC) and advanced cirrhosis. ... Based on the original clinical trials, the FDA believes the benefits of the drug
June 2021