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.

Click here to see the warning letter issued to Lantech Pharmaceuticals Limited. (Don’t have an FDAzilla PRO account? No problem! You can sign up for free here.)

Recent Citation Examples

Aurobindo 483 Snip

Glenmark 483 Snip

Lantech 483 Snip

 

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.”

Click here to see the warning letter issued to Lantech Pharmaceuticals Limited. (Don’t have an FDAzilla PRO account? No problem! You can sign up for free here.)

 

Want this and more?
Sign up to get free weekly content updates
designed to make your job easier
.

 

Learn how FDAzilla can help you achieve your quality and inspection preparation goals:
483s
InspectorProfiles
Enforcement Analytics
GMP Regulatory Intelligence

Contact us if you ever have questions at [email protected].

Like this post? Don't forget to share it!

Share on facebook
Share on twitter
Share on linkedin
Share on email
Share on print

Recent Posts

cropped-Z-Cloud

Don’t miss out! Subscribe now

Experience the Power of FDAzilla

Get your FREE account to search sites, inspections, & warning letters