Class I · High risk
Sodium Bicarbonate in 5% Dextrose Injection
Non-Sterility: firm's third party lab confirmed microbial contamination.
4 recalls · Class I, newest first
Non-Sterility: firm's third party lab confirmed microbial contamination.
Non-Sterility
Non-sterility.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of fungus, resulted in a breach of the package integrity.
Non-sterility.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of fungus, resulted in a breach of the package integrity.