FDA recall D-0535-2023

Product

Epinephrine Professional EMS, Epinephrine Convenience Kit, Epinephrine 1 mg/mL, Rx Only, Focus Health Group, Manufactured for: Focus Health Group, 5802 Kingston Pike, Knoxville, TN 37919. Incorrect NDC (kit): 24357-011-13

Reason for recall

Labeling; Incorrect NDC number on outer carton of product.

Distribution

Nationwide in the USA

Key facts

Status

Ongoing

Initiation date

2023-03-16

Report date

2023-04-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Knoxville, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0535-2023