FDA recall D-1325-2022

Mckesson Medical-Surgical Inc. Corporate Office · Class II · drug

Product

Racepinephrine Inhalation Solution, USP 2.25%, Bronchodilator, For Oral Inhalation Only, Sulfite Free, Preservative Free, 30 x 0.5 mL Sterile Unit-of-Use Vials, each in a foil pouch, per carton, Nephron Pharmaceuticals Corporation, NDC 0487-5901-99.

Reason for recall

CGMP Deviations: products were stored outside the drug label specifications.

Distribution

Nationwide in the USA.

Key facts

Status: Terminated
Initiation date: 2022-06-29
Report date: 2022-08-17
Termination date: 2024-02-13
Voluntary/Mandated: Voluntary: Firm initiated
Location: Richmond, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1325-2022