Estradiol Vaginal Inserts
Defective Delivery System: Customer complaints of malfunctioning plunger of the applicator
892 recalls · Class II, newest first
Defective Delivery System: Customer complaints of malfunctioning plunger of the applicator
Subpotent Drug: Expansion of June 2018 recall of lots S700065 and S700619 due to below specification results for assay.
CGMP Deviations
Failed dissolution specifications
CGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
Lack of sterility assurance.
Lack of sterility assurance.
Lack of sterility assurance.
Lack of sterility assurance.
Lack of sterility assurance.
Lack of sterility assurance.
Lack of sterility assurance.
Lack of sterility assurance.
Lack of sterility assurance.
Lack of sterility assurance.
Lack of sterility assurance.
Lack of sterility assurance.
Lack of sterility assurance.
Lack of sterility assurance.
Lack of sterility assurance.
Lack of sterility assurance.
Lack of sterility assurance.
Lack of sterility assurance.
Lack of sterility assurance.
Lack of sterility assurance.