Labeling: Illegible label: Manufacturer received complaint of mis-alignment print of the printed dosing instructions on the blister card.
Asclemed USA Inc.
Class I - Dangerous
Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.
Class I - Dangerous
Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.
Class I - Dangerous
Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.
Class I - Dangerous
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
Class I - Dangerous
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