Defective Container - A defect in the side-seal which allows leakage of product.
Teva Pharmaceuticals USA
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.
Presence of foreign tablets/capsules.
Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit
Superpotent Drug
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
Failed Dissolution Specifications
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 Dissolution Specifications
Class I - Dangerous
OOS for viscosity
Class I - Dangerous
Failed Moisture Limits: Water (moisture) content above the approved product specifications.
Class I - Dangerous
Labeling: Incorrect or Missing Package Insert
Class I - Dangerous
Labeling: Incorrect or Missing Package Insert
Class I - Dangerous
Labeling: Incorrect or Missing Package Insert
Class I - Dangerous
Labeling: Incorrect or Missing Package Insert
Class I - Dangerous
Labeling: Incorrect or Missing Package Insert
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.
Class I - Dangerous
CGMP Deviations: A foreign matter identified as teflon was found in the Active Pharmaceutical Ingredient (API) used in the manufacture of Neomycin Sulfate Tablets, USP 500 mg.
Class I - Dangerous
Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.
Failed Dissolution Specifications: below specification limits for dissolution.
Failed Dissolution Specifications: below specification limits for dissolution.
Superpotent Drug: Out of specification assay result was obtained during stability testing.
Class I - Dangerous
Failed Dissolution Specifications; Low Out of Specification (OOS) results for dissolution.
Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing
Class I - Dangerous
Failed Dissolution Specifications- Low Out-Of-Specification results obtained during stability testing.
cGMP Deviations
Presence of Particulate Matter: Product was found to contain silica and iron oxide
Mislabeling
Mislabeling
Failed Dissolution Specification: Dissolution results are below specification limits for the active ingredient
Class I - Dangerous
Failed Dissolution Specifications; Low Out of specification (OOS) results for dissolution.
Defective Container: The notch in the cap that fits into the nozzle of the dropper could break off and block the dropper possibly resulting in the product not dispensing.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Subpotent
Labelling: Incorrect Exp. Date
Failed Impurities/Degradation Specifications
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Class I - Dangerous
CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) for an excipient batch of Dibasic Calcium Phosphate.
Class I - Dangerous
CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) for an excipient batch of Dibasic Calcium Phosphate.
CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) for an excipient batch of Dibasic Calcium Phosphate.
Class I - Dangerous
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Class I - Dangerous
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Class I - Dangerous
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
Presence of Particulate Matter: Complaint received of a glass particle observed inside the vial. The vial was returned to Teva for further analysis where two other particulates were found and identified as one (1) grey silicone particle and one (1) translucent, colorless cotton fiber.
Class I - Dangerous
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
Failed Impurity/Degradation Specifications: Out-of-specifications results observed for impurities during stability testing.
Chemical contamination; Unknown brown residue adhering to the inside of one vial.
Class I - Dangerous
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 injectable products.
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 injectable products.
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 injectable products.
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 injectable products.
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 injectable products.
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 injectable products.
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 injectable products.
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 injectable products.
Class I - Dangerous
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 injectable products.
Class I - Dangerous
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 injectable products.
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 injectable products.
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 injectable products.
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 injectable products.
Class I - Dangerous
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 injectable products.
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 injectable products.
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.