Recent Statement Regarding ARB Recalls

Yesterday, Dr. Janet Woodcock, FDA Director of the Center for Drug Evaluation and Research, released a statement regarding the recent recalls of Angiotensin II Receptor Blockers (ARB).  The statement outlines the minimal risk to patients taking the medication from the exposure to potential carcinogens (N-Nitrosodiethylamine (NDEA)) contaminants in the active pharmaceutical ingredient (API) in the medicine.  The FDA also shares their efforts in learning how the contamination occurred and how to detect it in the future.

In a recent warning letter to Lantech Pharmaceuticals Limited in Telangana, India, the FDA found that Lantech is a contract solvent recovery facility for the API manufacturing operations.  The solvent they recovered contained the NDEA contaminant and a sufficient risk assessment of the Lantech process was not done as well as an impurity profile.

“Specifically, the warning letter cites Lantech’s failure to control and monitor procedures to recover solvents to ensure they meet appropriate standards before use.”  Additionally, Lantech was placed on import alert.

Recent Citation Examples

In conclusion, Dr. Woodcock assures the public that “The FDA has ongoing review, surveillance, compliance and pharmaceutical quality efforts across every product area, and we will continue to work with drug manufacturers to ensure safe, effective, and quality drug products for the American public.”