East Windsor, New Jersey, Eugia US LLC (f/k/a AuroMedics Pharma LLC) has initiated a voluntary recall of lot number 3MC23011 of Methocarbamol Injection, USP 1000 mg/10 mL (100mg/mL) (Single Dose Vial) - 10mL Vial to the consumer level...
Amneal Pharmaceuticals, LLC. Bridgewater, New Jersey (Amneal), is voluntarily recalling 4 lots (see table below) of Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL packaged in 80 mL, 150 mL, or 300 mL pack sizes, to the...
FDA warns consumers not to use certain over-the-counter pain relief products containing lidocaine that are marketed for topical use in cosmetic procedures like microdermabrasion, laser hair removal, tattooing and piercing, and issued...
The main focus of this research program is to study the mechanisms by which biological products or pathogens alter the functioning or integrity of the vascular system in both vascular endothelial cell culture systems and animal models.
The development of a safe and effective blood substitute would greatly improve the emergency treatment of accident victims and wounded soldiers, as well as patients undergoing cardiac surgery, especially when whole blood is in short supply.
Description of CBER's Rare Disease Program, including a description of the program, selected activities, examples of collaborations internal and external to CBER, and frequently asked questions.
Task Description Request Please post to the ORA Electronic Reading Room Record Date 01/26/2024 Short Title (70 char) Sentara Enterprises dba Sentara Infusion Services. Charlottesville, VA. State Referral Letter issued 01/26/2024 FEI...
Roland Foods, LLC (“Roland Foods”) of New York, New York is recalling a specific production code of Roland® Tahini (100% Ground Sesame Seeds) 16 oz. because it has the potential to be contaminated with Salmonella, an organism which can...
Task Description Request Please post to the ORA Electronic Reading Room Record Date 11/15/2023 Short Title (70 char) Catalent Indiana, LLC. Bloomington, IN. 483 issued 11/15/2023 FEI Number 3005949964 Firm Name Catalent Indiana, LLC...
Task Description Request Please post to the ORA Electronic Reading Room Record Date 06/07/2021 Short Title (70 char) Front Door Pharmacy, LLC dba Pure Pharmacy. Houston, TX. 483 issued 06/07/2021 FEI Number 3012937475 Firm Name Front...
Task Description Request Please post to the ORA Electronic Reading Room Record Date 12/20/2019 Short Title (70 char) Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical. Los Angeles, CA. Amended 483 issued 12/20/2019 FEI Number...
Task Description Request Please post to the ORA Electronic Reading Room Record Date 10/25/2023 Short Title (70 char) Stokes Healthcare Inc. dba Epicur Pharma. Mount Laurel, NJ. 483 issued 10/25/2023 FEI Number 3002815949 Firm Name Stokes...
The FDA approved Duvyzat (givinostat) oral medication for the treatment of Duchenne Muscular Dystrophy (DMD) in patients six years of age and older. Duvyzat is the first nonsteroidal drug approved to treat patients with all genetic...
Task Description Request Please post to the ORA Electronic Reading Room Record Date 05/26/2023 Short Title (70 char) Medi-Fare Drug. Blacksburg, SC. 483 issued 05/26/2023 FEI Number 3009925820 Firm Name Medi-Fare Drug Record Type 483...
InfuTronix, LLC has announced a voluntary recall of the Nimbus Ambulatory Infusion Pump System, including Nimbus II PainPro, Nimbus II Flex, Nimbus II Plus, Nimbus II EpiD and Nimbus II EMS from the US Market due to a high number (3698)...
Task Description Request Please post to the ORA Electronic Reading Room Record Date 07/14/2023 Short Title (70 char) Sentara Enterprises dba Sentara Infusion Services. Charlottesville, VA. 483 issued 07/14/2023 FEI Number 3025984445 Firm...
Task Description Request Please post to the ORA Electronic Reading Room Record Date 09/13/2021 Short Title (70 char) First Pharma Associates, LLC dba Riverpoint Pharmacy. Spokane, WA. Untitled Letter issued 09/13/2021 FEI Number...
Pyramid Wholesale is issuing a recall of various brands of products sold as dietary supplements for sexual enhancement because they contain undeclared prescription drugs including Sildenafil (Viagra) and/or Tadalafil (Cialis).
Lenmeldy is the first FDA-approved gene therapy indicated for the treatment of children with pre-symptomatic late infantile, pre-symptomatic early juvenile or early symptomatic early juvenile metachromatic leukodystrophy (MLD).
Wenders LLC of Dublin, CA is recalling specific production lots of Trader Joes Nuts – 50% Less Sodium Roasted & Salted Whole Cashews – (SKU Number – 37884) Lot# T12139, T12140, T12141, and T12142 because they have the potential to be...
The FDA approved the first medication for the treatment of adults with noncirrhotic non-alcoholic steatohepatitis (NASH) with moderate to advanced liver scarring, to be used along with diet and exercise.
Task Description Request Please post to the ORA Electronic Reading Room Record Date 08/29/2023 Short Title (70 char) Boothwyn Pharmacy LLC. Kennett Square, PA. Amended 483 issued 08/29/2023 FEI Number 1000076625 Firm Name Boothwyn...
Task Description Request Please post to the ORA Electronic Reading Room Record Date 09/18/2023 Short Title (70 char) SNF Holdings DBA VIOS Compounding. Livonia, MI. Untitled Letter issued 09/18/2023 FEI Number 3021886842 Firm Name SNF...
Kick Ash Products of Ellison Bay, WI is recalling Door County Love Dark Chocolate Cherry Granola with Lot #061241, because it may contain undeclared ALMONDS. People who have an allergy or severe sensitivity to almonds run the risk of...
The Food and Drug Administration is advising consumers not to purchase or use Govvi WOW!, a product promoted and sold for weight loss on various websites, including www.ebay.com and possibly in some retail stores.
Task Description Request Please post to the ORA Electronic Reading Room Record Date 10/16/2023 Short Title (70 char) Precision Equine LLC. Bakersfield, CA. 483 Response issued 10/16/2023 FEI Number 3005698544 Firm Name Precision Equine...
Endo International plc announced today that one of its operating companies, Par Pharmaceutical, Inc. (Par), is voluntarily recalling one lot of Treprostinil Injection 20mg/20mL (1mg/mL) to the consumer level. The product is being...
John B. Sanfilippo & Son, Inc (JBSS) announced today it is voluntarily recalling a limited amount of 8.25 oz Great Value Honey Roasted Cashews, because it may contain undeclared coconut and milk. People who have an allergy or severe...
FDA seeks $7.2 Billion to enhance food safety and nutrition, advance medical product safety, help support supply chain resiliency, strengthen the agency’s public-health and mission-support capacity, and modernize the FDA’s...