Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA ’ s steps on naming of biological medicines to balance competition and safety for patients receiving these products
FDA updates draft guidance to set a clear path for the nonproprietary naming of interchangeable biosimilars. (Source: Food and Drug Administration)
Source: Food and Drug Administration - March 7, 2019 Category: American Health Source Type: news
Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA ’s steps on naming of biological medicines to balance competition and safety for patients receiving these products
FDA updates draft guidance to set a clear path for the nonproprietary naming of interchangeable biosimilars. (Source: Food and Drug Administration)
Source: Food and Drug Administration - March 7, 2019 Category: American Health Source Type: news
McDaniel Life-Line LLC Issues Voluntary Worldwide Recall of Life-Line Water
McDaniel Life-Line LLC is voluntarily recalling all lots of Life-Line Water to the consumer level. This product is being recalled because FDA analysis found the product to be contaminated with Pseudomonas aeruginosa. (Source: Food and Drug Administration)
Source: Food and Drug Administration - March 6, 2019 Category: Food Science Source Type: news
FDA approves new nasal spray medication for treatment-resistant depression; available only at a certified doctor ’s office or clinic
FDA approved Spravato (esketamine) nasal spray, in conjunction with an oral antidepressant, for the treatment of depression in adults with treatment-resistant depression (Source: Food and Drug Administration)
Source: Food and Drug Administration - March 6, 2019 Category: American Health Source Type: news
Statement from FDA Commissioner Scott Gottlieb, M.D., and Susan Mayne, Ph.D., director of the Center for Food Safety and Applied Nutrition, on tests confirming a 2017 finding of asbestos contamination in certain cosmetic products and new steps that FDA is pursuing to improve cosmetics safety
(Source: Food and Drug Administration)
Source: Food and Drug Administration - March 5, 2019 Category: American Health Source Type: news
Statement from FDA Commissioner Scott Gottlieb, M.D., on forceful new actions focused on retailers, manufacturers to combat youth access to e-cigarettes as part of FDA ’s Youth Tobacco Prevention Plan
. (Source: Food and Drug Administration)
Source: Food and Drug Administration - March 4, 2019 Category: American Health Source Type: news
Apotex Corp. Issues Voluntary Nationwide Recall of Drospirenone and Ethinyl Estradiol Tablets, USP, 28x3 Blister Pack/Carton Due to Possibility of Missing/Incorrect Tablet Arrangement
Weston, Florida, Apotex Corp. is voluntarily recalling four lots of Drospirenone and Ethinyl Estradiol Tablets, USP to the patient /user level. The four recalled lots of Drospirenone and Ethinyl Estradiol Tablets, USP may possibly contain defective blisters with incorrect tablet arrangements and/or an empty blister pocket. The affected product is manufactured by Oman Pharmaceutical Products Co. LLC. Oman under the subcontract from Helm AG, Nordkanalstrasse 28, Hamburg, 20097, Germany. (Source: Food and Drug Administration)
Source: Food and Drug Administration - March 4, 2019 Category: Food Science Source Type: news
Sunstone Organics Issues Voluntary Nationwide Recall of Select Kratom Products Due to Potential Contamination by < em > Salmonella < /em >
Springfield, OR, Sunstone Organics is voluntarily recalling two lots of Sunstone Organics Kratom. These two lots include Sunstone Organics White Vein Kratom Lot 119 and Sunstone Organics Maeng Da Kratom Lot 124A in both capsules and powder form and in all sizes. The products have been found to potentially be contaminated with salmonella. (Source: Food and Drug Administration)
Source: Food and Drug Administration - March 1, 2019 Category: Food Science Source Type: news
Updated: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium /Hydrochlorothiazide Tablets, USP
Torrent Pharmaceuticals Limited is voluntarily recalling 60 lots of Losartan potassium tablets USP and 54 lots of Losartan potassium/ hydrochlorothiazide tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. (Source: Food and Drug Administration)
Source: Food and Drug Administration - March 1, 2019 Category: Food Science Source Type: news
Asia Foods Distributor Inc. Issues Allergy Alert on Undeclared Milk Allergens in “ Nova Salted Biscuit ”
Asia foods Distributor Inc of 56-29 56 Drive, Maspeth, NY 11378 is recalling its 14.08 ounce packages of “ Nova Salted Biscuit ” food treats because they may contain undeclared milk allergens. Consumers who are allergic to milk allergens may run the risk of serious or lifethreatening allergic reactions if they consume this product. (Source: Food and Drug Administration)
Source: Food and Drug Administration - March 1, 2019 Category: Food Science Source Type: news
Asia Foods Distributor Inc. Issues Allergy Alert on Undeclared Milk Allergens in “Nova Salted Biscuit”
Asia foods Distributor Inc of 56-29 56 Drive, Maspeth, NY 11378 is recalling its 14.08 ounce packages of “Nova Salted Biscuit” food treats because they may contain undeclared milk allergens. Consumers who are allergic to milk allergens may run the risk of serious or lifethreatening allergic reactions if they consume this product. (Source: Food and Drug Administration)
Source: Food and Drug Administration - March 1, 2019 Category: Food Science Source Type: news
AurobindoPharma USA, Inc. Initiates a Voluntary Nationwide Consumer Level Recall Expansion of 38 Lots of Amlodipine Valsartan Tablets USP and Valsartan Tablets, USP due to the detection of NDEA (N-Nitrosodiethylamine) Impurity.
AurobindoPharma USA, Inc. is conducting a voluntary recall expansion of 38 lots of Valsartan and Amlodipine and Valsartan tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. This recall is an expansion of the recall initiated 12/31/18 The impurity detected in the finished drug product is N-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) cl...
Source: Food and Drug Administration - March 1, 2019 Category: Food Science Source Type: news
FDA provides update on its ongoing investigation into ARB drug products; reports on finding of a new nitrosamine impurity in certain lots of losartan and product recall
FDA provides update on ongoing investigation into ARB drugs; new losartan recall announced (Source: Food and Drug Administration)
Source: Food and Drug Administration - March 1, 2019 Category: American Health Source Type: news
Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25 mg, 50 mg and 100 mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical Ingredient (API)
Camber Pharmaceuticals, Inc. is recalling 87 lots of Losartan Tablets USP 25 mg, 50 mg, and 100 mg to consumer level. This recall was prompted due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, Unit – I (API manufacturer). (Source: Food and Drug Administration)
Source: Food and Drug Administration - March 1, 2019 Category: Food Science Source Type: news
FDA warns CanaRx for selling unapproved, misbranded and unsafe imported drugs to unsuspecting Americans
FDA issued a warning letter to CanaRx for illegally distributing drugs into the U.S. that have not been approved by the FDA for safety and effectiveness. (Source: Food and Drug Administration)
Source: Food and Drug Administration - February 28, 2019 Category: American Health Source Type: news
