FDA recall D-1821-2015

Product

PHENYLephrine HCl, 50 mg added to 250 mL 0.9% Sodium Chloride Injection USP (200 mcg per mL), packaged in 250 ml bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd., Sugar Land, TX 77478, NDC# 61553-171-50

Reason for recall

Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2015-01-28

Report date

2015-09-30

Termination date

2017-01-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1821-2015