FDA and USDA announce key step to advance collaborative efforts to streamline produce safety requirements for farmers by aligning USDA program with FDA’s Produce Safety Rule requirements.
Category Archives: Food & Drug Recalls
FDA takes action against 53 websites marketing unapproved opioids as part of a comprehensive effort to target illegal online sales
FDA announced that it has warned nine online networks, operating a total of 53 websites, that they must stop illegally marketing potentially dangerous, unapproved and misbranded versions of opioid medications, including tramadol and oxycodone.
FDA warns companies to stop selling dangerous and illegal pure and highly concentrated caffeine products
FDA issued warning letters to the parties responsible for liquidcaffeine.com and Dual Health Body and Mind for illegally selling certain highly concentrated caffeine products.
Shearer’s Foods, LLC Issues an Allergy Alert for Undeclared Milk in Meijer Brand Dill Pickle Flavored Potato Chips
Shearer’s Foods, LLC of Massillon, OH is recalling Meijer brand 9.5 ounce packages of Dill Pickle Flavored Potato Chips because they may contain undeclared milk. People who are allergic to milk run the risk of serious or life-threatening allergic reaction if they consume this product.
FDA approves first biosimilar to Neulasta to help reduce the risk of infection during cancer treatment
FDA approves Fulphila (pegfilgrastim-jmdb) as the first biosimilar to Neulasta (pegfilgrastim) to decrease the chance of infection as suggested by febrile neutropenia in patients with non-myeloid cancer.
Hospira Issues a Voluntary Nationwide Recall for Two Lots of Naloxone Hydrochloride Injection, USP, in the Carpuject™ Syringe System due to the Potential Presence of Particulate Matter
Hospira, Inc., a Pfizer company, is voluntarily recalling lots 72680LL and 76510LL of Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL, Carpuject Single-use cartridge syringe system (NDC 0409-1782-69), to the hospital/institution level due to the potential presence of embedded and loose particulate matter on the syringe plunger.
Statement from FDA Commissioner Scott Gottlieb, M.D., on proposed modernization of FDA’s drug review office
FDA has proposed an important series of new steps to modernize the organization and functions of CDER’s Office of New Drugs.
Sanders Issues Allergy Alert on Undeclared Almonds in Fudge Mini Bites
Sanders announced today that it is recalling its 3.75oz Milk Chocolate Covered Fudge Mini Bites because they may contain undeclared almonds. People who have allergies to almonds run the risk of serious or life-threatening allergic reaction if they consume these products.
SDQ Trading Inc Issues Alert on Undeclared Milk Allergen in Cheese Biscuits
SDQ Trading Inc. of 651A Lexington Ave, Brooklyn, NY 11221 is recalling its 16.5 oz packages of Cheese Biscuits because they may contain undeclared milk allergen. Consumers who are allergic to milk allergen may run the risk of serious or life-threatening allergic reactions if they consume this product.
SunMed Holdings, LLC Issues a Nationwide Recall of STAT-Check and Medline Manual Resuscitator Bags
On May 29, 2018, SunMed Holdings, LLC initiated a nationwide recall of 18,808 units of STAT-Check and Medline resuscitator bags which were distributed between February 1, 2018 to May 13, 2018. The patient port retaining ring of the affected bags may not fully seat which may allow the patient port to detach during use. If this takes place, the resuscitator bags may not deliver air to the patient and result in a delay in treatment and life-threatening health consequences. There have been no reported injuries to date.