Enforcement Report - Week of October 6, 2021
Enforcement Report - Week of November 13, 2019
Advanced Botanical Consulting & Testing Inc dba ABC Testing Receives FDA Warning Letter
The Food and Drug Administration (FDA or Agency) has determined that QVAR 40 and QVAR 80 (beclomethasone dipropionate HFA) inhalation aerosol, 40 micrograms (mcg) and 80 mcg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for QVAR 40 and QVAR 80 (beclomethasone dipropionate HFA) inhalation aerosol, 40 mcg and 80 mcg, if all other legal and regulatory requirements are met.
Enforcement Report - Week of March 27, 2019
Enforcement Report - Week of June 20, 2018
Enforcement Report - Week of January 24, 2018
The regulatory agency said the liquid drugs and dietary supplement products produced by the Davie, Florida-based manufacturer could be potentially contaminated with the bacteria Burkholderia cepacia, which could cause severe patient infection.
Rugby Laboratories Issues Voluntary Nationwide Recall of Diocto Liquid and Diocto Syrup Manufactured By PharmaTech, LLC Due to Possible Product Contamination
APIs made by Laxachem Organics pvt ltd were not the source of bacteria in Pharmatech laxatives linked to a spate of Burkholderia cepacia infections according to the US Food and Drug Administration (FDA).