QuVa Pharma, Inc. recalls Norepinephrine 8 mg (32 mcg/mL) added to 0.9% Sodium Chloride Injection 250 mL Bag, Rx only, Compounded by: QuVA Pharma…

Recall date

November 21, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0295-2019

FDA classification

Class III

Brand / firm

QuVa Pharma, Inc.

Sold / distributed

CA only

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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