FDA recall D-0497-2019

Product

Oxytocin 10 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 1001 mL Sterile single use bag, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, NDC 42852-730-99.

Reason for recall

Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.

Distribution

Nationwide in the USA.

Key facts

Status

Terminated

Initiation date

2019-02-06

Report date

2019-02-27

Termination date

2019-10-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Houston, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0497-2019