Class II Recall

Plastikon Healthcare LLC

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
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; 21017A, EXP Feb. 2023; 21034A, 21036A EXP Mar. 2023; 21092A, EXP Aug. 2023; 21105A, 21106A, EXP Oct. 2023; 21134A, EXP Dec. 2023; 22007B, EXP Jan. 2024; 22012A, EXP Feb. 2024; 22016B, 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.