Endo Pharmaceuticals
Overview
Endo Pharmaceuticals is a healthcare company that specializes in the research, development, and marketing of pharmaceutical products. The company focuses on delivering quality branded and generic products, along with over-the-counter medications.
Therapeutic areas
API / Drug Master Files
Endo Pharmaceuticals holds 7 active (7 total) FDA Type II Drug Master Files — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.
- SACUBITRIL VALSARTAN TRISODIUM HEMIPENTAHYDRATEActive2025-05-24
- SERTRALINE HYDROCHLORIDE USP FORM-IActive2024-10-26
- SERTRALINE HYDROCHLORIDE USPActive2024-02-17
- VILDAGLIPTINActive2023-10-18
- DEXTROMETHORPHAN HYDROBROMIDE USPActive2021-07-26
- ALLOPURINOL USPActive2021-07-13
- METFORMIN HYDROCHLORIDE USPActive2011-11-03
FDA compliance signals
5 FDA enforcement records linked to this company.
- recall — Class I2024-08-07
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled as 0.125 mg instead of 0.25 mg. The blister strips inside the product carton reflect the correct strength of 0.25 mg.
- recall — Class II2023-04-05
Failed Impurities/Degradation Specifications and Subpotent Drug: High Out of Specification results for a known and unknown impurity as well as low Out of Specification results for assay.
- recall — Class I2018-10-10
Labeling: Incorrect Instructions: Dosage information on the immediate container label incorrectly states "Two to four tablets four times daily." rather than the correct dosage of "Two tablets three times daily."
- recall — Class II2017-03-15
Lack of Assurance of Sterility: Defective container resulting in the lack of sterility assurance. ok thanks
- recall — Class III2012-06-20
Adulterated Presence of Foreign Tablets: Customer complaint that some Endocet 10 mg/325 mg tablets were found mixed in a bottle with Endocet 10 mg/650 mg tablets.
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