Product: Diphenhydramine HCl Oral Solution 12.5 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 0904-6740-70
Reason for recall: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Recall initiated: 20220607
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated