FDA recall D-0930-2018

Product

ePHEDrine 50mg, 50 mg/10 mL (5 mg per mL) (Ephedrine Sulfate, USP 50mg in 0.9% Sodium Chloride, USPQS 10mL. 10 mL-Sterile use dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054 NDC 42852-805-61

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-0930-2018