FDA recall D-0003-2019

Product

Norepinephrine 4 mg (16 mcg/mL) added to 5% Dextrose 250 mL Bag Preservative Free, Rx only, QuVa Pharma, 519 Route 173, Bloombury, NJ 08804, UPC 70092103417.

Reason for recall

Subpotent Drug: Product may not have the active ingredient present in the bag.

Distribution

Nationwide to hospitals in USA

Key facts

Status

Terminated

Initiation date

2018-08-27

Report date

2018-09-26

Termination date

2019-04-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Sugar Land, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0003-2019