Prescription and over-the-counter medications
Aurobindo Pharma USA
Subpotent Drug: Out of Specification results for Assay
Vitae Enim Vitae Scientific
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
FAILED CONTENT UNIFORMITY SPECIFICATIONS
Defective Delivery System: Potential clogging of the needle preventing the dispensing of epinephrine.
Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability studies.
Defective Delivery System: Potential clogging of the needle preventing the dispensing of epinephrine.
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Jubilant Cadista Pharmaceuticals
Subpotent
CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit.
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Vitae Enim Vitae Scientific
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Mylan Pharmaceuticals
Subpotent Drug and Failed Impurities/Degradation Specifications: low out-of-specification results obtained for assay and high out-of-specification results for related substance impurities/degradation during routine stability testing.
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Vitae Enim Vitae Scientific
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Labeling: Incorrect Barcode: Product barcode incorrectly identifies the product as rocuronium bromide injection 100 mg per 10 mL instead of sodium chloride injection 23.4%, 120 mEq per 30 mL.
Revive Personal Products Company
Labeling; Label mix-up and Wrong Bar Code; back label incorrectly states active ingredient as Peppermint Oil and Sage Oil and has the wrong UPC
Presence of foreign substance: Presence of stainless steel particulates in tablets.
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Subpotent Drug and Presence of Particulate Matter: low out-of-specification results obtained for assay and the presence of particulate matter.