Diphenhydramine HCl Oral Solution, 25 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 0904-6741-72

Recall Number: D-1489-2022

Firm: Plastikon Healthcare LLC

Classification: Class II

Status: Terminated

Report Date: 20220914

Initiation Date: 20220607

Termination Date: 20250625

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

Diphenhydramine HCl Oral Solution, 25 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 0904-6741-72