There’s perhaps no more important mandate that we have at the FDA than safeguarding the health and safety of children. For that reason, I believe it’s important that parents and health care providers have the best information available to inform the decisions they make about a child’s health. There are few more common decisions that parents and providers are asked to make than the question of how to appropriately treat a child’s cough and cold symptoms. Sometimes symptoms can be severe enough that prescription medication is needed, but some of these medications pose their own risks – especially for younger children – because they may contain opioids. Other times medication might not be necessary at all.
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Bella Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of All Sterile Drug Products Due to Lack of Sterility Assurance
Bella Pharmaceuticals is voluntarily recalling all lots of unexpired sterile drug products due to lack of sterility assurance. The recalled products were distributed to health care facilities nationwide.
Vital Rx, Inc. d/b/a Atlantic Pharmacy and Compounding Issues Voluntary Nationwide Recall of all Compounded Injectable Prescription Medications Due to Lack of Sterility Assurance
Vital Rx, Inc. d/b/a Atlantic Pharmacy and Compounding is voluntarily recalling all lots of all compounded injectable prescription medications to the consumer level. The compounded injectable prescription medications have been found to lack sterility assurance. Atlantic Pharmacy and Compounding became aware of this issue during an FDA (Food and Drug Administration) inspection of the pharmacy.
FDA provides new tools for the development and proper evaluation of tests for detecting Zika virus infection
As an additional measure in the fight against Zika virus, today the U.S. Food and Drug Administration announced that it has made available a panel of human plasma samples to aid in the regulatory evaluation of serological tests to detect recent Zika virus infection.
FDA approves new treatment for adults with relapsed or refractory acute lymphoblastic leukemia
The U.S. Food and Drug Administration today approved Besponsa (inotuzumab ozogamicin) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
United Trading Inc. Issues Allergy Alert on Undeclared Sulfites in “Gazab Green Raisins (Chinese)”
United Trading Inc of Des Plaines, IL, is recalling its 7 ounce and 14 ounce packages of “Gazab Green Raisins (Chinese)”, because it may contain undeclared sulfites. People who have an allergy or severe sensitivity to sulfites run the risk of serious or life-threatening allergic reaction if they consume these products.
Seven Sundays LLC. Recalls Vanilla Cherry Pecan Muesli Because of Possible Health Risk
Seven Sundays LLC of Minneapolis, MN is recalling their Vanilla Cherry Pecan Muesli 12 oz. pouches because it may contain undeclared almonds. People who have an allergy or severe sensitivity to almonds run the risk of serious or life-threatening allergic reaction if they consume these products.
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Amneal Pharmaceuticals Issues Voluntary Nationwide Recall of Lorazepam Oral Concentrate, USP 2mg/mL, Due to Misprinted Dosing Droppers Supplied with the Product
Amneal Pharmaceuticals LLC is voluntarily recalling 13 lots of Lorazepam Oral Concentrate, USP 2mg/mL, to the Consumer level due to a defect in the dropper markings. The Lorazepam Oral Concentrate, USP 2mg/mL, product is packaged with a dosing dropper, supplied to Amneal by a third party.
Grand BK Corp. Issues Allergy Alert on Undeclared Tree Nuts (Almonds, Walnuts and Cashews) in "California Aloha Mix"
GRAND BK CORP. of Maspeth, New York is recalling its 14 ounce packages of “CALIFORNIA ALOHA MIX” because they may contain undeclared tree nuts (Almonds, Walnuts and Cashews). People who have allergies or severe sensitivity to tree nuts (Almonds, Walnuts and Cashews) run the risk of serious or life-threatening allergic reaction if they consume these products.
Dierbergs Markets Issues Allergy Alert on Undeclared Fish (Bonito and Cod), Lobster, Crab, Shrimp, Soy and Wheat in Product
St Louis-based Dierbergs Markets is recalling two Deli Products with multiple use by dates in all 25 retail stores due to the presence of undeclared fish (bonito, cod), undeclared lobster, crab, and shrimp in scampi butter and undeclared soy and wheat in cabernet grille butter. People who have allergies to fish, lobster, crab, shrimp, soy, or wheat run the risk of serious or life-threatening allergic reaction if they consume these products.