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Lack of Assurance of Sterility: Sterile products were not produced in a controlled, sterile environment.
CGMP Deviations
Marketed without an approved NDA/ANDA: Undeclared sibutramine.
Failed Dissolution Specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specification rates for the 10 hour testing point.
Failed Content Uniformity Specifications
Failed Stability Specifications: The recalled lots did not meet the specification for color and pH throughout shelf life.
Lack of Processing Controls: Isomeric Pharmacy Solution, LLC announces a voluntary field action for the Methylprednisolone Acetate/Lidocaine HCl 40/10 mg/mL Injection because the sterile injectable products were sterilized too long leading to potential difficulty resuspending particles.
Labeling; Incorrect or Missing Lot and/or Exp Date; incorrect expiration date on container label is 02/2019, correct expiration date should be 02/2018
Failed Impurities/Degradation Specifications
Failed Dissolution Specifications
Superpotent drug: Out of specification test result for assay during stability testing.
Crystallization: Product contains particulate identified to be crystallized active ingredient.
Bolthouse Farms is recalling 8 varieties of Protein Plus and Perfectly Protein drinks due to spoilage that may cause beverage to appear lumpy and have an unpleasant taste and odor.