Duloxetine prescription capsules recalled for N-nitroso impurity exceeding FDA limits
Breckenridge Pharmaceutical recalls Duloxetine 30mg delayed-release capsules nationwide due to N-nitroso-duloxetine impurity exceeding FDA-recommended interim limits. The impurity was identified as a CGMP manufacturing deviation.
- Product
- DULOXETINE — DULOXETINE (DULOXETINE HYDROCHLORIDE)
- Category
- Drug
- Distribution
- Distributed nationwide