Class I - Dangerous
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Astellas Pharma US
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Class I - Dangerous
Labeling: Label Error on Declared Strength
Class I - Dangerous
Failed Dissolution Specifications: The product did not meet the acceptance criteria for the dissolution test during the 24 month routine stability testing.
Lack of Assurance of Sterility; Astellas Pharma US, Inc. is performing a voluntary recall on certain lots of AmBisome because the manufacturer has notified Astellas that during a routine simulation of the manufacturing of AmBisome, a bacterial contamination was detected in the media fills.