The U.S. Food and Drug Administration announced today that the U.S. is now a “listed” country with the European Commission (EC) so that U.S. companies need not obtain an export certificate from the FDA before shipping certain pharmaceutical products to Europe.
DOJ News Release: The Department of Justice Files Suit Against Louisiana Pharmaceutical Company for Distributing Unapproved and Misbranded Prescription and Over-the-counter Drugs
Acting Assistant Attorney General Stuart F. Delery announced today that the Department of Justice, on behalf of the Food and Drug Administration (FDA), has filed suit in the U.S. District Court for the Western District of Louisiana against Sage Pharmaceuticals, Inc. (Sage), its president Dr. Jivn-Ren Chen, and its Director of Corporate Quality, Charles L. Thomas, all of Shreveport, Louisiana. According to the Complaint, the defendants violated the Federal Food, Drug, and Cosmetic Act (FDCA) by manufacturing and distributing unapproved and misbranded drug products. Under the FDCA, before a company can sell a new drug product to consumers, it must submit and receive approval of a new drug application from the FDA. The purpose of this approval process is to ensure that drugs manufactured and distributed to consumers are safe and effective for their intended uses. Furthermore, the FDA requires all drug labeling to have adequate directions for use.
FDA approves Plan B One-Step emergency contraceptive for use without a prescription for all women of child-bearing potential
Today, the U.S. Food and Drug Administration announced it has approved the use of Plan B One-Step (levonorgestrel) as a nonprescription product for all women of child-bearing potential. This action complies with the April 5, 2013 order of the United States District Court in New York to make levonorgestrel-containing emergency contraceptives available as an over-the-counter (OTC) product without age or point-of-sale restrictions.
Granna’s LLC Voluntarily Recalls Packages of #705 Tuna Mac With Italian Blend Vegetables and Spiced Apple Rings Due to Undeclared Eggs
Granna’s LLC is voluntarily recalling packages of #705 Tuna Mac that may contain an undeclared egg allergen. People who have an allergy or severe sensitivity to egg run the risk of serious or life-threatening allergic reaction if they consume this product.
FDA approves first genotyping test for patients with hepatitis C virus
The U.S. Food and Drug Administration today approved a test that identifies the genotype of hepatitis C virus (HCV) that a patient is carrying. The Abbott RealTime HCV Genotype II, which can differentiate genotypes 1, 1a, 1b, 2, 3, 4, and 5, using a sample of an infected patient’s blood plasma or serum, will aid health care professionals in determining the appropriate approach to treatment. Because the various HCV genotypes respond differently to available drug therapies, knowing the type of HCV a person is infected with can result in better patient outcomes.
Advance Pharmaceutical Inc. Issues Voluntary Recall of One Lot of Enteric Coated Aspirin Tablets, 81 mg, Due to Health Risk
Holtsville, NY, Advance Pharmaceutical Inc. today announced that this firm is conducting a voluntary nationwide recall to the user level of the over-the-counter drug product, Rugby label Enteric Coated Aspirin Tablets, 81 mg, Lot 13A026. Advance Pharmaceutical Inc. first initiated the recall on June 17, 2013, after receiving a complaint about a bottle labeled as Enteric Coated Aspirin Tablets, 81 mg, actually containing Acetaminophen 500 mg tablets.
Garden-Fresh Foods, Inc. Voluntarily Recalls Limited Packages of Archer Farms Smoked Salmon Dip Because of Possible Mislabeling
Garden-Fresh Foods Inc. is voluntarily recalling a limited number of packages of Archer Farms Smoked Salmon Dip that may contain undeclared allergens, fish and egg. Some of Archer Farms Smoked Salmon Dip may have inadvertently been filled in a limited amount of Bacon Parmesan Dip containers.
Oskri is Expanding the Recall of Fig Dark Chocolate Bars to Include Additional Lots. Lot: 161 through 164
OSKRI Corp. of Lake Mills, WI is recalling “Coconut Bar Dark Chocolate”, “Coconut Bar Dark Chocolate Minis”, “Fig Dark Chocolate Bars” and “Almond Dark Chocolate Bars” because the dark chocolate contains milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.
Natura Pet Issues Voluntary Recall of Specialized Dry Pet Foods Due to a Possible Health Risk
Natura Pet Products is voluntarily recalling specific lots of dry pet food because it has the potential to be contaminated with Salmonella. Salmonella can affect animals eating the products and there is risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.
FDA approves a new silicone gel-filled breast implant
The U.S. Food and Drug Administration today approved the MemoryShape Breast Implant to increase breast size (augmentation) for use in women at least 22 years old and to rebuild breast tissue (reconstruction) in women of any age. The MemoryShape Breast Implants are manufactured by Mentor Worldwide LLC.