Advanced Pharma Inc. recalls Oxytocin 10 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 1001 mL St…

Recall date

February 6, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0497-2019

FDA classification

Class III

Brand / firm

Advanced Pharma Inc.

Sold / distributed

Nationwide in the USA.

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.