FDA recall D-0964-2018

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

Product

ePHEDrine Sulfate, USP 50 mg in 0.9% Sodium Chloride, USP QS 10mL. 50 mg/10 mL (5 mg per mL). Volume 10 mL Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054 NDC 42852-895-61

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-0964-2018