FDA recall D-0778-2023

Product

Phenylephrine HCl 20 mg added to 0.9% Sodium Chloride 250mL Bag, Rx Only, Compounded by: Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, Massachusetts 01801-1042 United States, NDC 71546-451-25

Reason for recall

Product Mix up; Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride

Distribution

Nationwide in the USA.

Key facts

Status

Terminated

Initiation date

2023-05-22

Report date

2023-06-07

Termination date

2023-07-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Woburn, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0778-2023