Archive for the ‘Food & Drug Recalls’ category

Enovachem Pharmaceuticals Issues Voluntary Nationwide Recall of Dyural-40 and Dyural-80 Convenience Kits Containing Recalled Sodium Chloride Injection, USP, 0.9% Due to Latex Hazard

December 17, 2018

Torrance, CA, Asclemed USA Inc is voluntarily recalling 20 lots of Dyural-40 and 61 lots of Dyural-80, to the user level. The products include recalled Sodium Chloride, USP, 0.9% manufactured by Fresenius Kabi, which has been recalled due to product labeling incorrectly stating stoppers do not contain latex.

Michigan-based food manufacturer agrees to stop operations after repeated food safety violations

December 17, 2018

Saranac Brand Foods, Inc. specialized in a variety of 35 different ready-to-eat foods, including prepared salads, dips, and sauces.

Inspired Organics Issues Voluntary Recall of Organic Almond Butter Due to Potential Health Risk

December 17, 2018

Inspired Organics, LLC has issued a voluntary recall of Organic Almond Butter due to potential contamination of Listeria monocytogenes. Listeria monocytogenes is an organism, which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as […]

Spokane Produce Voluntarily Recalls Northwest Cuisine Creations and Fresh&Local Sandwiches and Green Leaf Lettuce Filets

December 16, 2018

Spokane Produce Inc. of Spokane, WA initiates a voluntary recall of sandwiches containing green leaf lettuce and foodservice lettuce filets following notice of a produce industry ingredient recall by Adam Bros. Farming Inc. Sandwich products bearing the Northwest Cuisine Creations and Fresh&Local labels. These prod- ucts are recalled because they may be contaminated with Escherichia […]

Apio, Inc. Voluntarily Recalls Five Skus of Eat Smart Single-Serve Salad Shake Ups™

December 15, 2018

Apio, Inc. of Guadalupe, California is voluntarily recalling five SKUs of Eat Smart® Single-Serve Salad Shake Ups™ (bowls). The recall comes after the Canadian Food Inspection Agency (CFIA) informed the company that one random sample of Eat Smart Single-Serve Salad Shake Ups Sweet Kale/Chou Frise Doux 156 gr. (5.5oz) with Best Before of Dec 14, […]

Statement from FDA Commissioner Scott Gottlieb, M.D. and FDA Deputy Commissioner Frank Yiannas on new findings and updated consumer recommendations related to the romaine lettuce E. coli O157:H7 outbreak investigation

December 13, 2018

Statement from FDA Commissioner Scott Gottlieb, M.D. and FDA Deputy Commissioner Frank Yiannas on new findings and updated consumer recommendations related to the romaine lettuce E. coli O157:H7 outbreak investigation

Statement from FDA Commissioner Scott Gottlieb, M.D. and Director of FDA’s Center for Drug Evaluation and Research Janet Woodcock, M.D., on efforts to modernize generic drug labels while maintaining the efficiency of generic development

December 13, 2018

FDA announces withdrawal of the proposed rule, Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products

Del Monte Foods Announces Limited Recall of Canned Fiesta Corn Seasoned with Red & Green Peppers Due to Under Processing

December 12, 2018

Del Monte Foods Inc. announced a recall of 64,242 cases of FIESTA CORN Seasoned with Red & Green Peppers due to under-processing. These deviations were part of the commercial sterilization process and could result in contamination by spoilage organisms or pathogens, which could lead to life-threatening illness if consumed. It is important to note that […]

Kimberly-Clark Announces Voluntary Recall of U by Kotex® Sleek® Tampons, Regular Absorbency,Throughout U.S. and Canada

December 12, 2018

Kimberly-Clark announced a voluntary product recall of its U by Kotex® Sleek® Tampons, Regular Absorbency, sold throughout the United States and Canada for a quality-related defect that could impact the performance of this product.

Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s efforts to improve drug quality through vigilant oversight of data integrity and good manufacturing practice

December 12, 2018

FDA releases guidance with recommendations for drug manufacturers regarding good manufacturing practices and data integrity

Moonstruck Chocolate Co. Issues Allergy Alert On Undeclared Hazelnuts In 4 Oz. Sea Salt Caramels Tumbled In Milk Chocolate

December 11, 2018

Moonstruck Chocolate Company of Portland, Oregon is recalling 600/4 oz. bags of Sea Salt Caramels Tumbled In Milk Chocolate, because it may contain undeclared hazelnuts. People who have an allergy or severe sensitivity to hazelnuts run the risk of a serious or life-threatening allergic reaction if they consume this product.

FDA warns API manufacturer involved in valsartan recall, provides information for patients taking these medications

December 11, 2018

FDA update on the ongoing investigation into angiotensin II receptor blocker impurities, recalls and current findings.

Inspired Organics Issues Voluntary Recall of Organic Sunflower Butter Due to Potential Health Risk

December 11, 2018

Inspired Organics, LLC has issued a voluntary recall of Organic Sunflower Butter due to potential contamination of Listeria monocytogenes. Listeria monocytogenes is an organism, which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as […]

Statement from FDA Commissioner Scott Gottlieb, M.D., on new actions advancing the agency’s biosimilars policy framework

December 11, 2018

FDA announces new actions advancing the agency’s biosimilars policy framework

Statement from Jeff Shuren, M.D., J.D., Director of the Center for Devices and Radiological Health, on updated safety communication about rates of duodenoscope contamination from preliminary postmarket data

December 10, 2018

FDA provides updates to postmarketing studies that agency ordered three manufacturers of duodenoscopes to conduct to assess bacterial contamination of devices.

FDA clears mobile medical app to help those with opioid use disorder stay in recovery programs

December 10, 2018

FDA clears a mobile medical application (app) to help increase retention (the amount of time a patient participates) in an outpatient treatment program for individuals with opioid use disorder

The J.M. Smucker Company Issues Voluntary Recall of Specific Lots of

December 10, 2018

The J.M. Smucker Company today announced a voluntary recall of specific lots of 9Lives® Protein Plus® wet, canned cat food due to possible low levels of thiamine (Vitamin B1). No illnesses related to this issue have been reported to date and the product is being recalled out of an abundance of caution.

The J.M. Smucker Company Issues Voluntary Recall of Specific Lots of 9Lives® Protein Plus® Wet, Canned Cat Food Due to Low Levels of Thiamine (Vitamin B1)

December 10, 2018

The J.M. Smucker Company today announced a voluntary recall of specific lots of 9Lives® Protein Plus® wet, canned cat food due to possible low levels of thiamine (Vitamin B1). No illnesses related to this issue have been reported to date and the product is being recalled out of an abundance of caution. Read The Complete […]

Statement from FDA Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Anna Abram on new efforts to assure the quality of compounded drugs

December 10, 2018

FDA releases guidance with recommendations for protecting patients from the risk of contaminated or substandard compounded products produced by outsourcing facilities.

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