FDA (Drugs) recall action 69243
The FDA (Drugs) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.
cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy upon receipt of a Rapid Alert Notification issued by The Italian Medicines Agency due to lack of good manufacturing practices.
The agency’s own wording, quoted from the enforcement report.
Gyma Laboratories of America, Inc. is recalling Clonidine HCL chemical product for medicines preparation due to lack of good manufacturing practices.
Gyma Laboratories of America, Inc. is recalling Propranolol HCl due to lack of good manufacturing practices identified by the Italian Medicines Agency.
Gyma Laboratories of America, Inc. is recalling Clonidine Base Micronized due to lack of good manufacturing practices identified by the Italian Medicines Agency.
Gyma Laboratories of America, Inc. is recalling Dipyridamole API due to lack of good manufacturing practices identified by the Italian Medicines Agency.