FDA recall D-0940-2018

Avella of Deer Valley, Inc. Store 38 · Class II · drug

Product

PHENYLephrine 40 mg (PHENYLephrine HCL (USP) 40 mg, 5%Dextrose Inj., USP 250 mL) Volume: 254 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-893-25

Reason for recall

Lack of Assurance of Sterility: Potential leakage of bags.

Distribution

Nationwide in the USA

Key facts

Status: Terminated
Initiation date: 2018-06-12
Report date: 2018-07-25
Termination date: 2020-01-24
Voluntary/Mandated: Voluntary: Firm initiated
Location: Phoenix, AZ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0940-2018