296 FDA recalls mention Estradiol. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Estradiol.
Reason Failed Content Uniformity Specifications: Out Of Specification test results observed for content uniformity.
Reason Failed Content Uniformity Specifications: Out Of Specification test results observed for content and blend uniformity.
Reason CGMP Deviations: Out of specification test result observed during retrospective review of blend uniformity test data.
Reason Failed Tablet/Capsule Specifications: Complaints related to crumbling of tablets when popped out of the blister pack.
Reason Defective Delivery System: complaints for difficulty in pushing the plunger of the applicator.
Reason Presence of Foreign Tablets/Capsules: Estradiol 1 mg was found in a 100 count bottle of Estradiol 0.5 mg Tablets.
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Failed dissolution specifications : failed results at the 3-month stability time point.
Reason Failed Impurities/Degradation Specifications: Kaitlib Fe Tablets has an out of specification result observed in long term stability study.
Reason Lack of Assurance of Sterility.
Reason Defective Delivery System: Estradiol Vaginal Inserts USP plunger is not functioning properly.
Reason Lack of sterility assurance.
Reason Failed Impurities/Degradation Specifications: Out-of-specification results observed in related substance test (Any Other Individual Impurity and…
Reason Contraceptive Tablets Out of Sequence: Missing or incorrect tablet placement.
Reason Defective Delivery System: Customer complaints of malfunctioning plunger of the applicator
Reason Presence of foreign tablet/capsule: A single foreign tablet was found in pharmacy dispensed bottle of 30 Estradiol 2 mg tablets.
Reason Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser contained instructions for the Dialpak dispenser.
Reason Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser contained instructions for the Dialpak dispenser.
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
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