FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Shutdown Approaches Third Week

Jan. 10, 2019

As the federal government shutdown nears the three-week mark, FDA Commissioner Scott Gottlieb continued to issue updates via Twitter in the absence of normal medial communications by the agency.

He used the platform last week to publicize a voluntary recall by Aurobindo Pharma of two lots of Valsartan, 26 lots of Amlodipine and Valsartan combination tablets, as well as 52 lots of Valsartan and HCTZ combination tablets due to contamination with NDEA. A December class-action lawsuit accused Aurobindo of knowingly selling the contaminated tablets.

Earlier last week, Gottlieb released a letter that tried to raise his staff’s morale, noting that “it’s in times of challenge and uncertainty that the public needs us most.”

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