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Prescription drugs recalled for contamination, potency or labelling.
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2,102 recalls · newest first
Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg.
Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.
Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
Labeling: Not Elsewhere Classified.
Labeling: Not Elsewhere Classified.
Microbial contamination of sterile products
Defective container:may contain bottles with incomplete seals
Defective container:may contain bottles with incomplete seals
Defective container:may contain bottles with incomplete seals
Defective container:may contain bottles with incomplete seals
Defective container:may contain bottles with incomplete seals
Defective container:may contain bottles with incomplete seals
Defective container:may contain bottles with incomplete seals
cGMP deviations
Subpotent Drug
Failed Stability Specifications
Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability…
CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
Failed Impurities/Degradations Specifications