FDA-Drug2022-09-14Class II
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
Plastikon Healthcare LLC
Hazard
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Sold states
Distributed Nationwide in the USA
Affected count
349,100 cups
Manufactured in
3780 Greenway Cir, N/A, Lawrence, KS, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1489-2022Don't want to check this manually?
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