HIGH
FDA DRUG
Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Martorelles, (Barcelona), Spain, Dist. by. Breckenridge Pharmaceutical, Inc.,...
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
DULOXETINE
CGMP Deviations;