FDA DrugClass IINotable
FDA Recall: Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutica
Description
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Hazard
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Remedy
165,761 90-count bottles
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