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FDAFDA · Food and drugs·Recall number D-0939-2018

NORepiNEPHrine 8 mg (norepinephrine Bitartrate (USP) 8 mg added to 5% Dextrose Inj. (USP) 250 mL. (Concentration 32 mcg/mL) Volume: 258 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr. Houston, TX 77054. NDC 42852-815-25

Published July 25, 2018 · Recall initiated: June 12, 2018

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Lack of Assurance of Sterility: Potential leakage of bags.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Avella of Deer Valley, Inc. Store 38
Distributor
Nationwide in the USA
Lot
Lot #4/23/18 0101 81525P, 4/23/18 1020 81525P, BUD 6/22/2018;4/30/18 1123 81525P, 4/30/18 1311 81525P, BUD 6/29/2018; 5/1/18 3456 81525P, BUD 6/30/2018; 5/8/18 3213 81525P, BUD 7/7/2018.
Risk classification
Class II
Area (FDA)
drug
Country
United States

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