Zero Count Adds Up To 70,000-Bottle Ranitidine Recall For AuroMedics
Additional recent recalls include 19,000 bottles of product marketed by Fitoterapia USA and labeled as liquid vitamin C but found to contain erectile dysfunction drug taldalafil .Ongoing testing of ranitidine drugs by FDA and manufacturers led to Aurobindo Pharma USA recall of one lot of OTC 150-mg tablets.
You may also be interested in...
Appropriators’ FDA FY 2021 budget includes amendment to expand its mandatory recall authority introduced by chairman of subcommittee with oversight of agency’s budget, Rep. Sanford Bishop. He said the agency should be able to force drug product recalls as it already can for vaccines, medical devices and products containing ingredients also scheduled as controlled substances.
Ranitidine no more carcinogenic than grilled meat, says FDA drug center director Janet Woodcock. Agency finds NDMA levels in ranitidine drugs well below those claimed by Valisure, online pharmacy asking FDA to order drug off US market.
Firms operating in the EU given six months to evaluate all OTC drugs containing chemically synthesized APIs for presence of nitrosamines, a probable human carcinogen. The order from EMA comes with a review of ranitidine underway after nitrosamine NDMA was detected in a number of OTC and Rx drugs.