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Prescription drugs recalled for contamination, potency or labelling.
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CGMP Deviations
CGMP Deviations
CGMP Deviations
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
CGMP Deviations
CGMP Deviations
CGMP Deviations
Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.
CGMP Deviations
Labeling: Incorrect or Missing Lot and/or Exp Date
CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024.
Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit.
Marketed Without an Approved NDA/ANDA
Labeling: Incorrect or Missing Lot and/or Exp Date
Labeling: Incorrect or Missing Lot and/or Exp Date
CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.
Lack of Assurance of Sterility:
CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable…
CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable…
Product mix up: complaint received that sealed medication bottle contained Carbidopa, Levodopa, and Entacapone film-coated tablets (37.5 mg/150…