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- Nearly 375,000 bottles of duloxetine delayed-release capsules were voluntarily recalled by Towa Pharmaceutical and distributed by Breckenridge Pharmaceutical due to N-nitroso-duloxetine levels exceeding FDA limits. - The impurity belongs to the nitrosamine class, some of which are probable human carcinogens; long-term exposure above acceptable levels may increase cancer risk. - The FDA classified the recall as Class II, indicating a remote probability of serious adverse health consequences or temporary, medically reversible effects. - Patients are advised to contact their healthcare provider before stopping the medication, as abrupt discontinuation may pose greater risks than the impurity exposure.
• Breckenridge Pharmaceutical receives FDA approval for its Methadone Hydrochloride Injection USP, a multi-dose vial formulation. • The injection is indicated for managing severe, persistent pain requiring extended opioid treatment when alternatives are inadequate. • It is also approved for temporary treatment of opioid dependence in patients unable to take oral medication. • This approval aligns with Breckenridge's strategy to expand its presence in the institutional channel with specialized products.
