This draft guidance provides information on the implementation of the statutory provision that authorizes FDA to require application holders for certain drug and biological products to make labeling changes based on new safety information that becomes available after approval of the drug.
Similar Posts
IF Copack LLC dba Initiative Foods Recalls “Tippy Toes” Brand Apple Pear Banana Because of Possible Health Risk
Sanger, CA – February 13, 2026 – IF Copack LLC d.b.a. Initiative Foods (“Initiative Foods”) is recalling one lot of the “Tippy Toes” brand Apple Pear Banana Fruit puree (“Product”) due to elevated levels of patulin. Patulin is a naturally occurring substance (called a mycotoxin) which is produced bBiosimilar Product Information
This page includes a chart of the approved biosimilar and interchangeable products. The approval of biosimilar products can improve access to care for patients by increasing the number of medication options and potentially lower costs.Natural MiracleZEN GOLD 60000 contains hidden drug ingredients
The Food and Drug Administration is advising consumers not to purchase or use Natural MiracleZEN GOLD 60000, a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores.Healwell Homeo Private Limited – 706206 – 06/12/2025
CGMP/Finished Pharmaceuticals/AdulteratedBlue Forest Farms, LLC – 711990 – 09/11/2025
Adulterated Human Foods/MisbrandedFromm Family Foods Voluntarily Recalls Bonnihill BeefiBowls Food for Dogs Due to Potential Foreign Material Contamination
MEQUON, WIS. (DECEMBER 3, 2025) – FROMM FAMILY FOODS has issued a recall of 300 cases of Bonnihill Farms BeefiBowls Beef Recipe gently cooked frozen dog food due to potential foreign plastic contamination.