PlainRecalls
FDA Drug Low Class III Terminated

Oxytocin 30 Units added to NS 500 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 503 mL Sterile single use bag, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, NDC 42852-706-50.

Reported: February 27, 2019 Initiated: February 6, 2019 #D-0499-2019

Product Description

Oxytocin 30 Units added to NS 500 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 503 mL Sterile single use bag, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, NDC 42852-706-50.

Reason for Recall

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

Details

Recalling Firm
Advanced Pharma Inc.
Units Affected
1460 bottles
Distribution
Nationwide in the USA.
Location
Houston, TX

Frequently Asked Questions

What product was recalled?
Oxytocin 30 Units added to NS 500 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 503 mL Sterile single use bag, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, NDC 42852-706-50.. Recalled by Advanced Pharma Inc.. Units affected: 1460 bottles.
Why was this product recalled?
Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.
Which agency issued this recall?
This recall was issued by the FDA Drug on February 27, 2019. Severity: Low. Recall number: D-0499-2019.