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Incredible Fish, Inc. is recalling a small quantity of Incredible Stone Crab Mustard Sauce because its labeling inadvertently did not identify the following allergens in the product: milk, fish, and eggs.

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FDA approved Veklury (remdesivir), the first drug approved to treat COVID-19, for use in adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of COVID-19 requiring hospitalization.

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Sunstar Americas Inc. Issues Voluntary Nationwide Recall of Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% Due to Microbial Contamination

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The FDA issued an immediately in effect guidance to revise its compliance policy regarding the deadline for filing premarket approval applications for previously cleared accessories that are necessary to operate automated external defibrillator (AED) systems.

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The FDA reminds harvesters that crops harvested from flooded fields are often unacceptable because of contamination. Flood waters, which are different from pooled rain water, may contain sewage, pathogenic organisms, pesticides, chemical wastes, or other toxic substances.

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Richwell Group, Inc., doing business as Maxfield Seafood, a City of Industry, Calif. firm and the importer of record, is recalling approximately 154,560 pounds of Siluriformes fish products that were not presented for import re-inspection into the United States.

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Consumers should not eat the recalled pre-cut melon products. The products were packaged in clear, plastic clamshell containers and distributed in IL, IN, IA, KA, KY, MN, MI, NE, NY, NC, OH, PA, TN, WV, and WI.

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FDA Investigating a Multistate Outbreak of Salmonella Carrau Linked to Pre-cut Melons

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Affected lots include:
Lot 180060 of Fentanyl Transdermal System, 12 mcg/h, expiration date 05/2020
Lot 180073 of Fentanyl Transdermal System, 12 mcg/h, expiration date 06/2020

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Alvogen, Inc. is voluntarily recalling two lots of Fentanyl Transdermal System 12 mcg/h transdermal patches to the consumer level. A number of cartons labeled 12 mcg/h Fentanyl Transdermal System patches contained 50 mcg/h patches. Manufactured by 3M Drug Delivery Systems.

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FDA is advising that rare but serious injuries have happened with certain common prescription insomnia medicines because of sleep behaviors, including sleepwalking, sleep driving, and engaging in other activities while not fully awake.

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Certain Prescription Insomnia Medicines: New Boxed Warning - Due to Risk of Serious Injuries Caused by Sleepwalking, Sleep Driving and Engaging in Other Activities While Not Fully Awake

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FDA Approves EVENITY (romosozumab-aqqg) for the Treatment of Osteoporosis in Postmenopausal Women at High Risk for Fracture

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JFC International Inc. Issues Allergy Alert on Undeclared Crustacean Shellfish (Shrimp, Crab) in Daisho Kimchi Hot Pot Soup Base

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Panera Bread Preemptively Recalls All 2 oz. and 8 oz. Cream Cheese Products

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Bulletproof 360, Inc. Issues Allergy Alert on Undeclared Milk in Collagen Protein Dietary Supplement

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Piller's Fine Foods Recalls Ready-To-Eat Salami and Speck Products due to Possible Salmonella Adulteration

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Rafedain Shish Kabob Restaurant, Inc. Recalls Chicken Patty Shish Kabob Products Due To Misbranding and Undeclared Allergens

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Magno-Humphries Laboratories, Inc., Issues Voluntary Nationwide Recall of Basic Drugs Brand of Senna Laxative Due to Mislabeling

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Products Pacheco Inc Issues Allergy Alert For Undeclared Wheat, Soy, Egg, Milk and Undeclared Artificial Coloring in its Bakery Products