FDA recall D-0777-2016

Product

NORepinephrine Bitartrate, 4 mg (16 mcg/mL) added to 250 mL 0.9% Sodium Chloride Injection USP, in 250 mL Viaflex Bag, Rx only, PharMEDium Services, LLC, Sugar Land, TX NDC 61553-134-61

Reason for recall

Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2015-12-31

Report date

2016-03-23

Termination date

2016-04-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0777-2016