Prescription and over-the-counter medications
Microbial Contamination of Non-Sterile Product: Product is being recalled to climatic Zone IV regions of the world where at the labeled storage conditions of 30*C/75% Relative Humidity for more than 6 months, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.
Teva Pharmaceuticals USA
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.
Teva Pharmaceuticals USA
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.
Wilshire Pharmaceuticals
Failed Dissolution Specifications
Labeling: Label Mix-Up. THe English label with Drug Facts panel for Camphor was incorrectly placed on product.
Failed Dissolution Specifications
CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit.
CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit.
Chemical Contamination: Products contain methanol and were below the label claim for ethanol content
Chemical Contamination: Products contain methanol and were below the label claim for ethanol content
Chemical Contamination: Products contain methanol and were below the label claim for ethanol content
Chemical Contamination: Products contain methanol and were below the label claim for ethanol content
Wilshire Pharmaceuticals
Failed Dissolution Specifications
Labeling; Label Mixup; syringe barrels may containing markings for 150 mg/mL (corresponding to 120 mg/0.8mL strength) instead of 100 mg/mL markings (corresponding to 100 mg/mL strength)
SUN PHARMACEUTICAL INDUSTRIES
Failed Impurity/Degradation Specifications
Stanley Specialty Pharmacy Compounding and Wellness Center
Superpotent Drug. Lidocaine higher concentration than listed
Labeling; Label Mix-up; correctly labeled 2 mL vials were packaged into blister strips labeled for 1 mL vials
Labeling; Label Mixup; syringe barrels may contain markings for 100 mg/mL (corresponding to 100 mg/mL strength) instead of 150 mg/mL (corresponding to 120 mg/0.8mL strength)
Nostrum Laboratories
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.
Failed Impurities/Degradation Specifications; Out-of-specification test results observed for Impurity C at 9 month long-term stability time point.