Ata Int. Inc. Issues Voluntary Nationwide Recall of BLUEFUSION Capsules, due to presence of Undeclared Sildenafil, Tadalafil, Desmethyl carbodenafil, Dithiodesmethyl carbodenafil, Scutellarin and Daidzein
Ata Int. Inc. is voluntarily recalling all lots within expiry of BLUEFUSION Capsules to the consumer level. FDA analysis has found the product to be tainted with sildenafil, tadalafil, desmethyl carbodenafil, dithiodesmethyl carbodenafil, scutellarin and daidzein. Sildenafil and tadalafil are FDA approved drugs for the treatment of male erectile dysfunction and are in a class of drugs called phosphodiesterase (PDE-5) inhibitors. Desmethyl carbodenafil and dithiodesmethyl carbodenafil are analogues of PDE-5 inhibitors and are likely to have the same pharmacological activity as PDE-5 inhibitors and thus carry the same clinic...
Source: Food and Drug Administration - March 21, 2019 Category: Food Science Source Type: news

Hill ’s Pet Nutrition Expands Voluntary Recall of Select Canned Dog Food for Elevated Vitamin D
Hill ’s Pet Nutrition today announced it is expanding its recall of select canned dog food products due to elevated levels of vitamin D. (Source: Food and Drug Administration)
Source: Food and Drug Administration - March 21, 2019 Category: Food Science Source Type: news

FDA approves new device for treating moderate to severe chronic heart failure in patients
Device to treat heart failure was given Breakthrough Device designation because it treats a life-threatening disease and addresses unmet clinical need. (Source: Food and Drug Administration)
Source: Food and Drug Administration - March 21, 2019 Category: American Health Source Type: news

Better Made Snack Foods Issues Allergy Alert on Undeclared Milk In 10 Ounce $3.99 Original Potato Chips
The recall was initiated after it was discovered that a package of 10-ounce Original Potato Chips dated 10 AUG 2019 did not contain Original Potato Chips but instead contained Cheddar and Sour Cream Potato Chips which contain milk. Subsequent investigation indicates the problem was caused by a temporary breakdown in the company's production and packaging processes which may have affected 660 bags of 10-ounce Original Potato Chips. (Source: Food and Drug Administration)
Source: Food and Drug Administration - March 21, 2019 Category: Food Science Source Type: news

Century Snacks LLC Recalls Snak Club Honey Bliss Nut Mix Due to Undeclared Allergen
Century Snacks, LLC of Commerce, CA is recalling all packages of 3-oz. and 5.75-oz. SNAK CLUB HONEY BLISS NUT MIX due to 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 21, 2019 Category: Food Science Source Type: news

Kingston Pharma, LLC RECALLS " DG ™/health NATURALS baby Cough Syrup + Mucus” Because of Possible Health Risk
Kingston Pharma, LLC of Massena, NY is recalling Lot KL180157 of its 2-fluid ounce (59 mL) bottles of DG ™/health NATURALS baby Cough Syrup + Mucus” because it has the potential to be contaminated with Bacillus cereus/ Bacillus circulans. Bacillus cereus in food products has the potential to produce two forms of gastrointestinal illness, one being a syndrome primarily of vomiting, and the other of diarrhea. Most often, illnesses are mild and self-limiting, although more serious and even lethal cases have occurred. Individuals at risk for more severe forms of illness include infants, young children, and others w...
Source: Food and Drug Administration - March 20, 2019 Category: Food Science Source Type: news

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 16, 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

Hometown Food Company Recalls Two Production LOT Codes of Pillsbury ® Unbleached All-Purpose 5lb Flour Due to Possible Health Risk
Please be advised the Hometown Food Company initiated a limited, voluntary retail-level recall on two specific lot codes of its Pillsbury ® Unbleached All-Purpose 5 lb Flour (UPC 51500-22241) because it may be contaminated with Salmonella. Only Best If Used By Dates APR 19 2020 and APR 20 2020 are impacted. (Source: Food and Drug Administration)
Source: Food and Drug Administration - March 13, 2019 Category: Food Science Source Type: news

Hometown Food Company Recalls Two Production LOT Codes of Pillsbury ® Unbleached All-Purpose 5lb Flour Due to Possible Health Risk
Please be advised the Hometown Food Company initiated a limited, voluntary retail-level recall on two specific lot codes of its Pillsbury ® Unbleached All-Purpose 5 lb Flour (UPC 51500-22241) because it may be contaminated with Salmonella. Only Best If Used By Dates APR 19 2020 and APR 20 2020 are impacted. (Source: Food and Drug Administration)
Source: Food and Drug Administration - March 13, 2019 Category: Food Science Source Type: news

Statement from FDA Commissioner Scott Gottlieb, M.D., on advancing new policies aimed at preventing youth access to, and appeal of, flavored tobacco products, including e-cigarettes and cigars
. (Source: Food and Drug Administration)
Source: Food and Drug Administration - March 13, 2019 Category: American Health Source Type: news

FDA approves a new generic valsartan
FDA has approved a new generic of Diovan (valsartan). The agency prioritized the review of this drug application to help relieve a recent shortage of the drug. (Source: Food and Drug Administration)
Source: Food and Drug Administration - March 12, 2019 Category: American Health Source Type: news

Claire ’s Stores, Inc., Announces Voluntary Recall of Three Make-Up Products
Out of an abundance of caution, today Claire ’s Stores, Inc., announced a voluntary recall of three cosmetic products: Claire’s Eye Shadows, Claire’s Compact Powder and Claire’s Contour Palette. We initiated this voluntary recall after testing by the U.S. Food and Drug Administration indicated the possible presence of asbestos fibers i n product samples from one lot of each product. Inhalation of asbestos over time has been linked to serious adverse health consequences. (Source: Food and Drug Administration)
Source: Food and Drug Administration - March 12, 2019 Category: Food Science Source Type: news

Claire ’ s Stores, Inc., Announces Voluntary Recall of Three Make-Up Products
Out of an abundance of caution, today Claire ’ s Stores, Inc., announced a voluntary recall of three cosmetic products: Claire ’ s Eye Shadows, Claire ’ s Compact Powder and Claire ’ s Contour Palette. We initiated this voluntary recall after testing by the U.S. Food and Drug Administration indicated the possible presence of asbestos fibers in product samples from one lot of each product. Inhalation of asbestos over time has been linked to serious adverse health consequences. (Source: Food and Drug Administration)
Source: Food and Drug Administration - March 12, 2019 Category: Food Science Source Type: news

Federal judge enters consent decree against Texas compounder, Guardian Pharmacy Services
A federal court ordered a Texas-based company to stop producing compounded drug products intended to be sterile until the company complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act). (Source: Food and Drug Administration)
Source: Food and Drug Administration - March 12, 2019 Category: American Health Source Type: news

Statement from FDA Commissioner Scott Gottlieb, M.D., on Administration ’ s request for new FDA funding to continue to advance robust regulatory framework for oversight of e-cigarettes, prevent youth access and initiation; and harness innovation to advance the safety of food, compounded drugs, U.S. blood supply
FDA is requesting new funding to continue to advance robust regulatory framework for oversight of e-cigarettes and harness innovation to advance the safety of food, compounded drugs, U.S. blood supply. (Source: Food and Drug Administration)
Source: Food and Drug Administration - March 11, 2019 Category: American Health Source Type: news

Statement from FDA Commissioner Scott Gottlieb, M.D., on Administration ’s request for new FDA funding to continue to advance robust regulatory framework for oversight of e-cigarettes, prevent youth access and initiation; and harness innovation to advance the safety of food, compounded drugs, U.S. blood supply
FDA is requesting new funding to continue to advance robust regulatory framework for oversight of e-cigarettes and harness innovation to advance the safety of food, compounded drugs, U.S. blood supply. (Source: Food and Drug Administration)
Source: Food and Drug Administration - March 11, 2019 Category: American Health Source Type: news

Fullei Fresh Recalls Organic Bean Sprouts Because of Possible Health Risk
Fullei Fresh of Miami, Florida is voluntarily recalling Organic Bean Sprouts because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. (Source: Food and Drug Administration)
Source: Food and Drug Administration - March 8, 2019 Category: Food Science Source Type: news

FDA takes steps to help reduce risks associated with surgical staplers and implantable staples
(Source: Food and Drug Administration)
Source: Food and Drug Administration - March 8, 2019 Category: American Health Source Type: news

Statement from FDA Commissioner Scott Gottlieb, M.D., on continued efforts to advance safe biotechnology innovations, and the deactivation of an import alert on genetically engineered salmon
(Source: Food and Drug Administration)
Source: Food and Drug Administration - March 8, 2019 Category: American Health Source Type: news

Norbrook Laboratories Limited Recalls Veterinary Products for Health Risk
Norbrook Laboratories Limited of Newry, Northern Ireland is recalling two lots of Enroflox ® 100 Injection (enrofloxacin), two lots of Noromectin ® Injection (ivermectin) and two lots of Ivermax ® 1% Injection (ivermectin) to the veterinarian/consumer level as a precautionary measure as product sterility cannot be assured. There is a concern that if the sterility of these products has been compromised, use of these products could result in introduction of infectious agents to the animal. This may result in the need for medical intervention(s) including, but not limited to the need for supportive care, antibioti...
Source: Food and Drug Administration - March 7, 2019 Category: Food Science Source Type: news

American Health Packaging Issues Voluntary Nationwide Recall of Valsartan Tablets Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity
American Health Packaging is voluntarily recalling one lot of Valsartan Tablets, USP, 160 mg to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. 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) classification. This recall is being initiated in response to the recall by the manufacturer (Aurobi...
Source: Food and Drug Administration - March 7, 2019 Category: Food Science Source Type: news

USDA and FDA Announce a Formal Agreement to Regulate Cell-Cultured Food Products from Cell Lines of Livestock and Poultry
USDA ’s Food Safety and Inspection Service and FDA announce a formal agreement to jointly oversee the production of human food products derived from the cells of livestock and poultry (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

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
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