Prescription and over-the-counter medications
Asclemed USA Inc.
Labeling: Not eslewhere classified - The kits include Sodium Chloride, USP, 0.9% which was recalled by the manufacturer due to the product insert incorrectly stating stoppers do not contain latex. The stoppers contain natural rubber latex
Sub-potent
CBI Laboratories
Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients.
Superpotent Drug: recalled lots may have higher concentration of ibuprofen.
Pharm D Solutions
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Superpotent Drug.
GE Healthcare Inc. Life Sciences
Defective Container: vial defect was identified that could potentially impact the container closure and result in a lack of sterility assurance and/or the potential for glass particles.
Asclemed USA Inc.
Labeling: Not eslewhere classified - The kits include Sodium Chloride, USP, 0.9% which was recalled by the manufacturer due to the product insert incorrectly stating stoppers do not contain latex. The stoppers contain natural rubber latex
Subpotent Drug: Isotretinoin content results were lower than the specification limit obtained during routing product monitoring.
Lack of Sterility Assurance and Incorrect/Undeclared excipient: Product was found to contain undeclared colloidal silver
Presence of foreign tablet/capsule: A single foreign tablet was found in pharmacy dispensed bottle of 30 Estradiol 2 mg tablets.
Superpotent Drug: recalled lots may have higher concentration of ibuprofen.
Labeling: Wrong bar code
Failed Dissolution Specifications.
Sub-potent
Failed Impurities/Degradation Specifications:Out of specification for impurities.
Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients.
Glenmark Pharmaceuticals Inc., USA
Shortfill: Aprepitant capsules 40 mg is being recalled due to customer reports of missing capsule in the blister pack.
Superpotent Drug: contains higher levels of Iron than labeled.
Mylan Laboratories Limited, (Nashik FDF)
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.