Plastikon Healthcare LLC recalls Diphenhydramine HCl Oral Solution 12.5 mg / 5 mL, 5 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Insti
Recalled September 14, 2022 · FDA recall D-1488-2022 · Plastikon Healthcare
Hazard
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled. · FDA Class II
Units
217,700 cups
Sold at
Distributed Nationwide in the USA
Description
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
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
Manufacturer(s)
Plastikon Healthcare LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →