Class II Recall

Plastikon Healthcare LLC

Product
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
Reason
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Classification
Class II
Status
Terminated
Lot
Lot # 20065A, EXP Jun. 2022; 20068A, 20070A, EXP Jul. 2022; 20097A, 20098A, EXP Oct. 2022; 21055A, EXP May. 2023; 21083A, EXP Jul. 2023; 21091A, EXP Aug. 2023; 21112A, EXP Oct. 2023
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.