methylprednisolone tablets
Reason Labeling: Not Elsewhere Classified. Incorrect orientation of the blister foil applied to the blister cavities, which results in incorrect dosing information when following the directions on the foil.
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Reason Labeling: Not Elsewhere Classified. Incorrect orientation of the blister foil applied to the blister cavities, which results in incorrect dosing information when following the directions on the foil.
Reason Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities.
Reason Superpotent and Subpotent
Reason Superpotent and Subpotent
Reason Presence of Foreign Substance
Reason cGMP deviations.
Reason Presence of Particulate Matter.
Reason Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Reason Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Reason Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Reason Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Reason Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Reason Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Reason Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Reason Out of specification for dissolution.
Reason Product Mix-Up: A single bottle of this lot was reported by a pharmacy to contain 88 mcg tablets instead of 150 mcg tablets.
Reason Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules
Reason Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
Reason Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.
Reason Incorrect Product Formulation: product did not contain insulin as listed in the label.
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and expiration date coding on the bottles.
Reason CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Reason CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Reason CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Reason CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.