CGMP/Finished Pharmaceuticals/Adulterated
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FDA approves drug to improve functional capacity and symptoms in adults with rare inherited heart condition
The U.S. Food and Drug Administration (FDA) approved Myqorzo (aficamten) tablets to treat adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms.Matrixx Initiatives Inc. (Zicam), Scottdale, AZ 483 issued 5/28/2009, EIR signed 5/27/2005, and 483 issued 5/27/2005 (23 pages)
Matrixx Initiatives Inc. (Zicam), Scottdale, AZ 483 issued 5/28/2009, EIR signed 5/27/2005, and 483 issued 5/27/2005 (23 pages)www.d-pharmacy.com – 711075 – 07/16/2025
Unapproved New Drugs/MisbrandedLibby Laboratories, Inc. – 708259 – 06/27/2025
CGMP/Finished Pharmaceuticals/AdulteratedA2A integrated Logistics Inc – 02/24/2025
A2A integrated Logistics Inc – 02/24/2025. Country: United States. Record Type: 483PRIME FOOD PROCESSING LLC ISSUES ALLERGY ALERT ON UNDECLARED (MILK) IN LAVA BUN W/ SALTED EGG YOLK AND LAVA BUN WITH GREEN TEA FLAVOR
Prime Food Processing LLC of Brooklyn, NY is voluntarily recalling 2,243 cases of two dessert bun varieties because the packaging does not declare milk in the “Contains” allergen statement as required by the U.S. Food and Drug Administration (FDA). The milk in these products is derived from unsalted