💊 Drugs • 12,141 recalls
Well Care Compounding Pharmacy
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Well Care Compounding Pharmacy
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Well Care Compounding Pharmacy
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: Products were found to be tainted with undeclared hydroxythiohomosildenafil, an analogue of Sildenafil, an FDA-approved drug for the treatment of male Erectile Dysfunction (ED), making them unapproved new drugs.
Defective Delivery System; may have a low frequency assembly fault which may result in pens block during the so-called "air shot" step
Well Care Compounding Pharmacy
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Pharmedium Services
Labeling: Not Elsewhere Classified: Potassium Chloride was printed on Potassium Phosphate label stock thereby having both names on the label of a 250 mL bag of Potassium Chloride.
Well Care Compounding Pharmacy
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Aidarex Pharmaceuticals
Failed Impurity/Degradation Specifications: Out of specifications for unknown impurity.
Well Care Compounding Pharmacy
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: Products were found to be tainted with undeclared hydroxythiohomosildenafil, an analogue of Sildenafil, an FDA-approved drug for the treatment of male Erectile Dysfunction (ED), making them unapproved new drugs.
Well Care Compounding Pharmacy
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Well Care Compounding Pharmacy
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Baptist Health Medical Towers Pharmacy and Infusion Services
Lack of Sterility Assurance
Invisiblu International
Marketed Without An Approved NDA/ANDA: Contains an unapproved drug, ligandrol LGD-4033
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Lack of Assurance of Sterility; some lots failed Antimicrobial Effectiveness Testing on stability