FDA recall D-1489-2022

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 for recall

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

Distribution

Distributed Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2022-06-07

Report date

2022-09-14

Termination date

2025-06-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lawrence, KS, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1489-2022