Prescription Drug Duloxetine Recalled for Nitrosamine Impurity Exceeding FDA Limits
Breckenridge Pharmaceutical recalls Duloxetine 60mg capsules nationwide due to N-nitroso-duloxetine impurity levels exceeding FDA interim limits. Affected lots had current good manufacturing practice (CGMP) deviations.
- Product
- DULOXETINE — DULOXETINE (DULOXETINE HYDROCHLORIDE)
- Category
- Drug
- Distribution
- Distributed nationwide