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.
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile…
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile…
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile…
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile…
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile…
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile…
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile…
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile…
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile…
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile…
Superpotent Drug: High out-of-specification assay results were obtained during stability testing.
Failed Dissolution Specifications: Out-of-specification dissolution results were obtained during stability testing.
Failed Stability Specifications: Below specification result for buprenorphine release rate.
CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits.
CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits.
Sub-Potent Drug: Out of specification test results for potency (below specification).
Labeling: Incorrect or Missing Lot and/or Exp date on the individual transdermal pouches but not in the carton.
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Some bottles may contain mixed strengths of the product.
Some bottles may contain mixed strengths of the product.
Some bottles may contain mixed strengths of the product.
CGMP Deviations: Precautions taken due to Out-of-specification for trigger force for a non-marketed lot number that shares the same component.
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
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.
