FDA approves first treatment for post-partum depression
FDA approves Zulresso (brexanolone), the first drug for post-partum depression (Source: Food and Drug Administration)
Source: Food and Drug Administration - March 19, 2019 Category: American Health Source Type: news
FDA issues warning letters to two breast implant manufacturers for failure to comply with post-approval study requirements
(Source: Food and Drug Administration)
Source: Food and Drug Administration - March 19, 2019 Category: American Health Source Type: news
Statement from FDA Commissioner Scott Gottlieb, M.D., and Deputy Commissioner Frank Yiannas on new steps to strengthen FDA ’s food safety program for 2020 and beyond
New steps to strengthen FDA ’s food safety program for 2020 and beyond (Source: Food and Drug Administration)
Source: Food and Drug Administration - March 19, 2019 Category: American Health Source Type: news
FDA takes action against marketer of unapproved products claiming to treat addiction, chronic pain and other serious conditions
FDA warned Nutra Pharma for illegally marketing unapproved products with claims about their ability to treat addiction, pain and other serious conditions. (Source: Food and Drug Administration)
Source: Food and Drug Administration - March 19, 2019 Category: American Health Source Type: news
Mylan Institutional LLC Initiates Voluntary Nationwide Recall of Levoleucovorin Injection Due to the Presence of Particulate Matter
Mylan Institutional LLC is conducting a voluntary nationwide recall of two lots (see table below) of Levoleucovorin Injection, 250 mg/25 mL to the consumer/user level. The lots were manufactured by Alidac Pharmaceuticals Limited and distributed by Mylan Institutional LLC. (Source: Food and Drug Administration)
Source: Food and Drug Administration - March 18, 2019 Category: Food Science Source Type: news
Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 50mg 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)
Legacy Pharmaceutical Packaging, LLC is recalling 3 repackaged lots of Losartan Tablets USP 50mg to the consumer level. This recall was prompted due to Torrent Pharmaceuticals LTD issuing a Voluntary Nationwide Recall of Losartan Tablets, USP, 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, (API manufacturer). (Source: Food and Drug Administration)
Source: Food and Drug Administration - March 16, 2019 Category: Food Science Source Type: news
Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25mg, 50mg, And 100mg 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)
Earth City, MO, Legacy Pharmaceutical Packaging, LLC is recalling 40 repackaged lots of Losartan Tablets USP 25mg, 50mg, and 100mg to the consumer level. This recall was prompted due to Camber Pharmaceuticals, Inc. issuing a Voluntary Nationwide Recall of Losartan Tablets, USP, 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, (API manufacturer). (Source: Food and Drug Administration)
Source: Food and Drug Administration - March 15, 2019 Category: Food Science Source Type: news
Hospira, Inc. Issues a Voluntary Nationwide Recall of 8.4% Sodium Bicarbonate Injection, USP Due to the Presence of Particulate Matter
Hospira, Inc., a Pfizer company, is voluntarily recalling lot numbers 79-238-EV, 79-240-EV and 80-088-EV, NDC# 0409-6625-02, of 8.4% Sodium Bicarbonate Injection USP, 50 mEq/50 mL (1 mEq/mL), to the Hospital/Institution level. The recall was initiated due to the presence of particulate matter, confirmed as glass. (Source: Food and Drug Administration)
Source: Food and Drug Administration - March 15, 2019 Category: Food Science Source Type: news
Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on efforts to evaluate materials in medical devices to address potential safety questions
The FDA is working to further evaluate materials like metals that are used in medical devices to learn more about how these materials interact with the immune system. (Source: Food and Drug Administration)
Source: Food and Drug Administration - March 15, 2019 Category: American Health Source Type: news
Surtidoras Bakery Inc. Issues Allergy Alert on Undeclared Milk in Marble Muffin, Banana Muffin, and Blueberry Muffin
Surtidoras Bakery Inc. of Auburn, Washington is recalling Marble Muffin, Banana Muffin, and Blueberry Muffin because it may contain undeclared 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. (Source: Food and Drug Administration)
Source: Food and Drug Administration - March 15, 2019 Category: Food Science Source Type: news
Statement from FDA Commissioner Scott Gottlieb, M.D., and Deputy Commissioner Frank Yiannas on advancing new tools and science for implementing agricultural water requirements for produce safety
FDA implements agricultural water requirements for produce safety (Source: Food and Drug Administration)
Source: Food and Drug Administration - March 15, 2019 Category: American Health Source Type: news
FDA allows marketing of new device to help treat carbon monoxide poisoning
FDA allows marketing of a new device, ClearMate, intended to be used with patients suffering from carbon monoxide poisoning. This is the first carbon monoxide poisoning device authorized for marketing by the FDA for use in an emergency room setting. (Source: Food and Drug Administration)
Source: Food and Drug Administration - March 14, 2019 Category: American Health Source Type: news
Statement by FDA Commissioner Scott Gottlieb, M.D., on new strategies to modernize clinical trials to advance precision medicine, patient protections and more efficient product development
FDA issues statement on new strategies to modernize clinical trials to advance precision medicine, patient protections and more efficient product development (Source: Food and Drug Administration)
Source: Food and Drug Administration - March 14, 2019 Category: American Health Source Type: news
FDA approves new indication for valve repair device to treat certain heart failure patients with mitral regurgitation
Device is for treatment of patients to reduce mitral regurgitation in certain patients with heart failure symptoms who fail to respond to traditional therapy (Source: Food and Drug Administration)
Source: Food and Drug Administration - March 14, 2019 Category: American Health Source Type: news
Stokes Healthcare Inc. Issues Voluntary Nationwide Recall of Pilocarpine 0.1% Ophthalmic Solution Due to a High Level of Preservative
Stokes Healthcare Inc. is voluntarily recalling 1 lot of 81 units of Pilocarpine 0.1% Ophthalmic Solution, to the consumer and veterinarian office levels. The ophthalmic solution has been found to contain a higher level of the preservative benzalkonium chloride than is typical. (Source: Food and Drug Administration)
Source: Food and Drug Administration - March 13, 2019 Category: Food Science Source Type: news
