Lisinopril Tablets USP, 10 mg, 1000-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland…
Reason Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
17,898 recalls, newest first
Reason Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
Reason CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
Reason Marketed Without An Approved NDA/ANDA; Unapproved new drug
Reason Marketed Without An Approved NDA/ANDA; Unapproved new drug
Reason CGMP Deviations: FDA analysis found product to contain acetaldehyde impurity and the Sum of All Impurities, above specification limits.
Reason cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which…
Reason cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which…
Reason Labeling: Not Elsewhere Classified - Incorrect label-incorrect scent listed on label.
Reason Labeling: Label Error on Declared Strength; A sealed 100-count bottle labeled with 15 mg actually contained 100 tablets of 20 mg strength of the drug…
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 Lack of Assurance of Sterility
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 Lack of Assurance of Sterility
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 Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility