Prescription and over-the-counter medications
Pacific Compounding Pharmacy & Consultations
Presence of Particulate Matter: Particulate matter was reported in one lot of Cefuroxime by a physician after use of product.. FDA analysis identified the particulate as coring of the rubber stopper
Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
Failed Impurities/Degradation Specifications: Out-of-specification results observed in related substance test (Any Other Individual Impurity and Total impurities) in Ethinyl Estradiol Tablets USP 0.01mg at 12 month long term stability study.
Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
Ata International
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared ingredients: Sildenafil, Tadalafil, desmethyl carbodenafil, dithiodesmethyl carbodenafil, scutellarin, and daidzein.
Ingenus Pharmaceuticals
Defective Container: firm discovered samples stored horizontally as well as product quality complaints from customers for bottles leaking.
cGMP Deviations
Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
Defective Container: Repetitive complaints received indicating pump not working.
Iso-Tex Diagnostics
Lack of Assurance of Sterility: preliminary environmental monitoring report exceeds limits, therefore sterility cannot be assured.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient
Lack of Assurance of Sterility
Rx Pak Division of McKesson
Labeling: Label mix-up: Secondary carton may be labeled as Gabapentin 300mg instead of Docusate Sodium 100mg softgel caps.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient