Overview of recall records associated with Teva Pharmaceuticals USA, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 37, Class III: 17, Class I: 1.
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
CGMP Deviations: use of an unapproved raw material
CGMP Deviations: use of an unapproved raw material
CGMP Deviations: use of an unapproved raw material
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Defective Container - A defect in the side-seal which allows leakage of product.
Subpotent drug; Clavulanate Potassium component
CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.
CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.
CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.
Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit
Failed Impurities/Degradation Specifications: Product is being recalled due to API related substances and unknown impurities that are above the specification limits.
Subpotent Drug
Superpotent Drug: The 3-month stability result for assay was found to be above specification limit
Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Failed Moisture Limits: Water (moisture) content above the approved product specifications.
Failed Impurities/Degradation Specifications: failed impurities for Sulphoxide and Impurity A.
Failed Impurities Specification: Out-of-specification (OOS) stability test result was obtained for unspecified impurity.
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Labeling: Label Error on Declared Strength; A sealed 100-count bottle labeled with 15 mg actually contained 100 tablets of 20 mg strength of the drug product.
This page summarizes recall records in which the official source identifies Teva Pharmaceuticals USA, Inc. 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.
