Overview of recall records associated with Teva Pharmaceuticals USA, including dates, categories and classifications where available.
Classification mix: Class II: 120, Class III: 23, Class I: 4.
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.
Failed Dissolution Specifications: Low out of specification dissolution result observed during stability testing.
Labeling: Incorrect package insert - Patient leaflets for the specified lots of unscored tablets contain language relative to a 25 mg dosing titration that necessitates the use of a scored…
GMP Deviations: Product bottle may be absent of desiccant.
GMP Deviations: Product bottle may be absent of desiccant.
GMP Deviation: lot not intended for commercial distribution.
Subpotent Product: assay results for Amoxicillin were below the specification limits.
Subpotent Drug.
Failed dissolution specifications
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Failed dissolution specifications: Out-of-Specification dissolution test result obtained during routine stability testing.
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
This page summarizes recall records in which the official source identifies Teva Pharmaceuticals USA as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.
