FDA recall D-0295-2019

Product

Norepinephrine 8 mg (32 mcg/mL) added to 0.9% Sodium Chloride Injection 250 mL Bag, Rx only, Compounded by: QuVA Pharma 1075 West Park One Drive Suite 100 Sugar Land, TX 77478. Product Code 70092-9035-05

Reason for recall

Incorrect excipient: Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride

Distribution

CA only

Key facts

Status

Terminated

Initiation date

2018-11-21

Report date

2018-12-19

Termination date

2019-05-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Sugar Land, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0295-2019