Plastikon Healthcare LLC recalls GUAIFENESIN AND DEXTROMETHORPHAN 200-20 mg/10 mL, 10 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Inst
Recalled September 14, 2022 · FDA recall D-1491-2022 · Plastikon Healthcare
Hazard
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled. · FDA Class II
Units
246,200 cups
Sold at
Distributed Nationwide in the USA
Description
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Product
GUAIFENESIN AND DEXTROMETHORPHAN 200-20 mg/10 mL, 10 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152, NDC 0904-6980-72
Manufacturer(s)
Plastikon Healthcare LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →