Recall
Active
FDA
Official source
Ajanta Pharma Ltd.: Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, Recall
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals. Product details:...
- Company
- Ajanta Pharma Ltd.
- Deadline
- No deadline listed
- Source
- U.S. Food and Drug Administration