Ottogi America, Inc. Issues Allergy Alert on Undeclared Egg in Products
Ottogi America, Inc. announced today it is recalling below 21 items due to a possibility of containing egg ingredient undeclared on the packages. People who have an allergy or severe sensitivity to eggs run the risk of serious or life-threatening allergic reaction of they consume these products. (Source: Food and Drug Administration)
Source: Food and Drug Administration - January 19, 2019 Category: Food Science Source Type: news
Prinston Pharmaceutical Inc. issues Voluntary Nationwide Recall of Irbesartan and Irbesartan HCTZ Tablets Due to detection of a Trace Amount of Unexpected Impurity, N- nitrosodiethylamine (NDEA) in the Products
-- Prinston
Pharmaceutical Inc., dba Solco Healthcare LLC., has initiated a voluntary recall of one (1) lot of Irbesartan and seven (7) lots of Irbesartan HCTZ Tablets to the consumer level due to the detection of trace amount of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. (Source: Food and Drug Administration)
Source: Food and Drug Administration - January 18, 2019 Category: Food Science Source Type: news
Statement from FDA Commissioner Scott Gottlieb, M.D., on unprecedented new efforts to support development of over-the-counter naloxone to help reduce opioid overdose deaths
FDA describes unprecedented new efforts to support development of over-the-counter naloxone to help reduce opioid overdose deaths (Source: Food and Drug Administration)
Source: Food and Drug Administration - January 17, 2019 Category: American Health Source Type: news
FDA approves first generic version of Sabril to help treat seizures in adults and pediatric patients with epilepsy
FDA approved the first generic version of Sabril for treating complex partial seizures, as an adjunctive therapy in certain patients. (Source: Food and Drug Administration)
Source: Food and Drug Administration - January 16, 2019 Category: American Health Source Type: news
RXBAR Recalls Certain Varieties of Bars Due to a Potential Undeclared Peanut Allergen
RXBAR is voluntarily recalling certain varieties of bars because they may contain undeclared peanuts. People who have peanut allergies run the risk of serious or life-threatening allergic reaction if they consume this product. (Source: Food and Drug Administration)
Source: Food and Drug Administration - January 16, 2019 Category: Food Science Source Type: news
Voluntary Recall Notice of El Guapo Chile Habanero and Chile Pasilla-Ancho Pouches Due to Unlabeled Peanut Allergen
Mojave Foods Corporation is initiating a voluntary recall of El Guapo Chile Habanero and Chile Pasilla-Ancho pouches due to an unlabeled peanut allergen. (Source: Food and Drug Administration)
Source: Food and Drug Administration - January 16, 2019 Category: Food Science Source Type: news
Statement from FDA Commissioner Scott Gottlieb, M.D. and Peter Marks, M.D., Ph.D., Director of the Center for Biologics Evaluation and Research on new policies to advance development of safe and effective cell and gene therapies
FDA describes new policies to advance development of safe and effective cell and gene therapies (Source: Food and Drug Administration)
Source: Food and Drug Administration - January 15, 2019 Category: American Health Source Type: news
Happy Together, Inc. Issues Voluntary Nationwide Recall of Product Due to Presence of Undeclared Sildenafil and Tadalafil
Happy Together, Inc. Boynton Beach, FL is voluntarily recalling all lots within expiry of the Rhino 5k capsules to the consumer level. FDA analysis founds these products to be tainted with sildenafil and Tadalafil. Sildenafil/Tadalafil is an FDA approved drug for the treatment of erectile dysfunction, the presence of sildenafil in the Rhino 5k products renders them unapproved drugs for which safety and efficacy have not been established, therefor subject to recall. (Source: Food and Drug Administration)
Source: Food and Drug Administration - January 8, 2019 Category: Food Science Source Type: news
Sun Pharmaceutical Industries, Inc. Issues Voluntary Nationwide Recall of Vecuronium Bromide for Injection Due to the Presence of Particulate Matter Identified as Glass
Sun Pharmaceutical Industries, Inc. (SPII), a wholly owned subsidiary of Sun Pharmaceutical Industries, Ltd. is voluntarily recalling three lots of Vecuronium Bromide for Injection, 10 mg (lyophilized powder), and one lot of Vecuronium Bromide for Injection, 20 mg (lyophilized powder) to the hospital level. The Vecuronium Bromide for Injection has been found to contain particulate matter identified as glass. (Source: Food and Drug Administration)
Source: Food and Drug Administration - January 8, 2019 Category: Food Science Source Type: news
Grand Strand Sandwich Company Recalls Lunch Box Sandwiches Italian Subs Lunch Box Sandwiches Ham & Swiss Croissants And Lunch Box Sandwiches Ham & Cheese Due To Possible < em > Listeria Monocytogenes < /em > Contamination
– Grand Strand Sandwich is recalling Lunch Box Italian Subs, Lunch Box Ham& Swiss Croissants and Lunch Box Ham& Cheese Frozen Wedges due to a potential contamination ofListeria Monocytogenes. (Source: Food and Drug Administration)
Source: Food and Drug Administration - January 8, 2019 Category: Food Science Source Type: news
Hy-Vee Voluntarily Recalls Cheesecakes Made with Diamond Crystal Mix
Hy-Vee, Inc., based in West Des Moines, Iowa, is voluntarily recalling its cheesecakes made with Diamond Crystal Brands cheesecake mix due to the potential that they may be contaminated with Salmonella. The potential for contamination was brought to Hy-Vee ’s attention today after receiving a letter from the supplier. The voluntary recall includes 32 varieties of cheesecakes in both 8-ounce and 32-ounce packages with best if used by dates of Dec. 6, 2018, through Jan. 11, 2019. No illnesses have been reported to date. (Source: Food and Drug Administration)
Source: Food and Drug Administration - January 7, 2019 Category: Food Science Source Type: news
Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency ’ s new actions under the Pre-Cert Pilot Program to promote a more efficient framework for the review of safe and effective digital health innovations
FDA issues three documents that launch next phase of Pre-Cert Pilot Program to test new approaches for the review of digital health device applications. (Source: Food and Drug Administration)
Source: Food and Drug Administration - January 7, 2019 Category: American Health Source Type: news
Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency ’s new actions under the Pre-Cert Pilot Program to promote a more efficient framework for the review of safe and effective digital health innovations
FDA issues three documents that launch next phase of Pre-Cert Pilot Program to test new approaches for the review of digital health device applications. (Source: Food and Drug Administration)
Source: Food and Drug Administration - January 7, 2019 Category: American Health Source Type: news
Lupin Pharmaceuticals, Inc. Issues Voluntary Recall of Ceftriaxone for Injection USP, 250mg, 500mg, 1g and 2g
Lupin Pharmaceuticals, Inc. is voluntarily recalling 5 lots of Ceftriaxone for Injection, USP, 250mg, 10 lots of Ceftriaxone for Injection, USP, 500mg, 24 lots of Ceftriaxone for Injection, USP, 1g and 3 lots of Ceftriaxone for Injection, USP 2g, to the hospital/physician level. The products have been found to contain visual grey particulate matter in reconstituted vials. (Source: Food and Drug Administration)
Source: Food and Drug Administration - January 5, 2019 Category: Food Science Source Type: news
Olde York Potato Chips Issues Allergy Alert on Undeclared Milk in One Lot of Clancy's Wavy Potato Chips 10 Oz
Olde York Potato Chips of
Brampton, Ontario is recalling Clancy ' s Wavy Potato Chips 10 oz (UPC 0 41498 16306 8) with the specific lot code BEST If Used By FEB 22 19 1A6 because they 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. No other lot codes and no other products are involved in this action. (Source: Food and Drug Administration)
Source: Food and Drug Administration - January 4, 2019 Category: Food Science Source Type: news
