Vecuronium Bromide for Injection 20 mg* *1mg/mL when reconstituted to 20 mL Lyophilized, 10 recall — FDA D-0373-2019
Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection.
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10,690 detailed records are currently available in this category.
Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection.
Subpotent
Lack of Assurance of Sterility: Confirmed customer complaints for leaks on the tubing.
Subpotent Drug: Expansion of June 2018 recall of lots S700065 and S700619 due to below specification results for assay.
Lack of sterility assurance.
Labeling: Label Error on Declared Strength: Label incorrectly lists concentration as "10 mcg per mL" rather than the correct concentration of "100 mcg per mL".
Failed Dissolution Specifications
Failed Dissolution Specifications
Superpotent Drug: recalled lots may have higher concentration of ibuprofen.
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…
Sub-potent
Superpotent Drug: recalled lots may have higher concentration of ibuprofen.
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.
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…
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
Superpotent Drug: recalled lots may have higher concentration of ibuprofen.
Sub-potent
Failed Impurities/Degradation Specifications:Out of specification for impurities.
Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients.
Shortfill: Aprepitant capsules 40 mg is being recalled due to customer reports of missing capsule in the blister pack.
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
cGMP violations noted during the firm's most recent inspection.
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
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