💊 Drugs • 3,313 recalls
Medline Industries
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Medline Industries
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Defective Container: products showed leakage (bubbles, foaming) of propellant and product from the container valve cup area.
Medline Industries
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Johnson & Johnson
Defective Container: products showed leakage (bubbles, foaming) of propellant and product from the container valve cup area.
Microbial Contamination of Non-Sterile Products.
Failed Stability Specifications:stability failure at 12 months, long term RT conditions.
Failed Stability Specifications:stability failure at 12 months, long term RT conditions.
GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination
Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination
GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
Pharmedium Services
Superpotent Drug
GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination
GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination
B. Braun Medical
Presence of Particulate Matter: identified as polyethylene, which is consistent with the material used to manufacture the contain cap
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared sildenafil and tadalafil and undeclared milk. The presence of sildenafil and tadalafil makes AMPT Natural Herbal Coffee an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall. Additionally, this product has been found to contain undeclared milk, milk is recognized as one of the foods reported to have caused deaths due to anaphylactic shock in persons with underlying hypersensitivities.