161 recalls, newest first
Reason Failed Stability Specification: Water determination was found not complying with specification.
Reason CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Reason CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Reason CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Reason CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Reason CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Reason Failed Impurities/Degradation Specifications: Out-of-specification test results.
Reason Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ingredient found in FDA approved products for the…
Reason CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was exposed to controlled room temperature environment…
Reason Failed Stability Specifications: Out of specification for blend uniformity.
Reason Failed Dissolution Specifications: results slightly under spec at at 9-months.
Reason an out of specification result obtained during routine stability testing for Impurities. There is a remote possibility that use of this product…
Reason cGMP Deviations: Products were stored outside the drug label specifications.
Reason cGMP Deviations: Products were stored outside the drug label specifications.
Reason cGMP Deviations: Products were stored outside the drug label specifications.
Reason Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Reason Labeling: Incorrect or Missing Package Insert
Reason CGMP Deviations: Inadequate induction sealing on bottles, capsules were observed with bubbles on band seal, capsules with holes and spheres sticking…
Reason CGMP Deviations
Reason CGMP Deviations
Reason CGMP Deviations: Potential Glass and Silicone particulates in product
Reason CGMP Deviations: Potential Glass and Silicone particulates in product
Reason CGMP Deviations: Potential Glass and Silicone particulates in product
Reason CGMP Deviations: Potential Glass and Silicone particulates in product
Reason CGMP Deviations: Potential Glass and Silicone particulates in product