💊 Drugs • 12,141 recalls
Breckenridge Pharmaceutical
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Breckenridge Pharmaceutical
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Nephron Sterile Compounding Center
Lack of Assurance of Sterility: There is a potential for leakage at the IV bottle port.
Central Admixture Pharmacy Services
Presence of Particulate Matter
Breckenridge Pharmaceutical
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Labeling: Label Error on Declared Strength. Cases labeled POTASSIUM CHLORIDE 20 mEq, may contain flexible containers with overwrap mislabeled as 10 mEq. The correct dosage strength of 20 mEq is printed on the labeling affixed to the product flexible container.
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
SUN PHARMACEUTICAL INDUSTRIES
Failed Dissolution Specifications
Failed Impurities/Degradation Specifications
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Failed Impurities/Degradation Specifications
Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product.
Lack of Assurance of Sterility: due to a quality control process deviation. During an internal quality assurance review, an Acceptable Quality Limit (AQL) inspection was not conducted on a statistically sound number of samples. This may result in the inability to assure that the impacted products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess and may lead to products of unacceptable quality.
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.