RecallRadar

FDA Drug recall D-0959-2018

NORepiNEPHrine Bitartrate, USP 160 mcg in 5% Dextrose, USP QS 10mL. Volume 10mL. Single dose syringe

On 2018-07-25 the FDA classified a Class II recall of NORepiNEPHrine Bitartrate, USP 160 mcg in 5% Dextrose, USP QS 10mL. Volume 10mL. Single dose syringe by Avella Of Deer Valley Store 38, citing lack of Assurance of Sterility: Potential leakage of bags.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0959-2018
ClassificationClass II
Statusterminated
Initiated2018-06-12
Published2018-07-25
Last updated2026-09-13 11:52 UTC
CompanyAvella Of Deer Valley Store 38
DistributionUS

Product

NORepiNEPHrine Bitartrate, USP 160 mcg in 5% Dextrose, USP QS 10mL. Volume 10mL. Single dose syringe. Avella of Houston, 9265 Kirby Dr. Houston, TX 77054. NDC 42852-807-61

Reason

Lack of Assurance of Sterility: Potential leakage of bags.

Identifiers

code_infoLot #: 5/7/18 0301 2-80761S, BUD 6/21/2018; 5/9/18 0510 2-80761S, BUD 6/23/2018; 5/21/18 1807 80761S, BUD 7/15/2018.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0959-2018%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.