Prescription Drugs

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Marketed Without An Approved NDA/ANDA: Unapproved Drug based on label claims.

Lack of Assurance of Sterility

Marketed Without An Approved NDA/ANDA: Unapproved Drug based on label claims.

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing.

cGMP - Water leakage

Labeling: Label Mix-up: bottles labeled as Morphine Sulfate 60 mg Extended-Release tablets contain Morphine Sulfate 30 mg Extended-Release tablets and bottles labeled as Morphine Sulfate 30 mg Extended-Release tablets may contain Morphine Sulfate 60 mg Extended-Release tablets.

Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac and dexamethasone.

Labeling: Label Mix-up: bottles labeled as Morphine Sulfate 60 mg Extended-Release tablets contain Morphine Sulfate 30 mg Extended-Release tablets and bottles labeled as Morphine Sulfate 30 mg Extended-Release tablets may contain Morphine Sulfate 60 mg Extended-Release tablets.

CGMP Deviations: Manufacturing deviations were reported due to an abnormal appearance on parts of machinery.

CGMP Deviations

CGMP Deviations

CGMP Deviations

Microbial Contamination of a Non-Sterile Products: Testing of product onfirmed the presence of Gluconacetobacter Liquefaciens

CGMP Deviations