Presence of foreign substance: plastic-like substance.
MACLEODS PHARMA USA
Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63) in the distributed bottles.
Shortfill: customer complaints of one to three tablets were reported missing from 30 count bottles.
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
FAILED CONTENT UNIFORMITY SPECIFICATIONS
cGmp Deviations
cGMP deviations
Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
Presence of foreign matter
Failed Impurities/Degradation Specifications
Subpotent Drug: Out of specification assay result, below specification, for two lots of Pioglitazone And Metformin Hydrochloride Tablets.
Failed Dissolution Specifications: testing revealed low out of specification result in one lot of product
Superpotent
Subpotent Drug: Out of specification result during stability study in Pramipexole Dihydrochloride Tablets 0.125 mg
Failed Dissolution Specifications
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
Failed Content Uniformity Specifications: The product is out of specification for blend uniformity.
Failed Content Uniformity Specifications: The product is out of specification for blend uniformity.
Failed Content Uniformity Specifications: The product is out of specification for blend uniformity.
Presence of Foreign Tablets/Capsules: Presence of a comingled Carbimazole 5 mg tablet.