FDA recall D-0954-2018

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

Product

MORphine 150 mg (Morphine Sulfate, USP 150mg in 0.9% Sodium Chloride, USP QS 30mL). Volume 30 mL. Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-243-63

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-0954-2018