Class II Recall

Plastikon Healthcare LLC

Product
GUAIFENESIN AND DEXTROMETHORPHAN 100 mg-10 mg/5 mL, 5 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 0904-6844-70
Reason
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Classification
Class II
Status
Terminated
Lot
Lot # 20091A, EXP Sep. 2022; 20104A, EXP Nov. 2022; 21013A, EXP Feb. 2023; 21041A, EXP Apr. 2023; 21102A, EXP Sep. 2023; 21121A, 21127A, EXP Nov. 2023; 22003A, 22007A, EXP Jan. 2024; 22016A, EXP Mar. 2024
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.