Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • R&D 100 Awards

Oxytocin Compounded with Lactated Ringers/Dextrose Recalled Due to Low Potency

By FDA | September 5, 2017

PharMEDium Services, LLC issues voluntary nationwide recall of all unexpired lots of oxytocin compounded with either lactated ringers or lactated ringers and dextrose due to sub-potency.

PharMEDium Services, LLC (PharMEDium) is voluntarily recalling all unexpired lots of Oxytocin compounded with Lactated Ringers and all unexpired lots of Oxytocin compounded with Lactated Ringers and Dextrose products that were produced between July 6, 2017 and August 29, 2017 to the hospital/user level.  The recall is being issued based on laboratory test results indicating a lower than expected potency on certain lots of Oxytocin compounded with Lactated Ringers and Oxytocin Compounded with Lactated Ringers and Dextrose which would lead to a lower dose being administered. While the lower than expected potency results affected only certain lots of Oxytocin compounded with Lactated Ringers and Oxytocin Compounded with Lactated Ringers and Dextrose, in an abundance of caution, PharMEDium is recalling all unexpired lots of Oxytocin compounded with Lactated Ringers and all unexpired lots of Oxytocin compounded with Lactated Ringers and Dextrose.   To date, PharMEDium has received four reports of product complaints related to the products.

Per the oxytocin package insert, oxytocin is indicated for the initiation or improvement of uterine contractions, where this is desirable and considered suitable for reasons of fetal or maternal concern, in order to achieve vaginal delivery. It is indicated for (1) induction of labor in patients with a medical indication for the initiation of labor, such as Rh problems, maternal diabetes, preeclampsia at or near term, when delivery is in the best interests of mother and fetus or when membranes are prematurely ruptured and delivery is indicated; (2) stimulation or reinforcement of labor, as in selected cases of uterine inertia; (3) as adjunctive therapy in the management of incomplete or inevitable abortion. In the first trimester, curettage is generally considered primary therapy. In second trimester abortion, oxytocin infusion will often be successful in emptying the uterus. Other means of therapy, however, may be required in such cases or to control postpartum evacuation/ bleeding.

Although oxytocin is titrated based on clinical response, an extreme and unexpected reduction in dose than expected could lead to a delay in treatment, disruption of clinical care of the patient, and worsening of patient’s conditions.

These products were packaged in ready to use intravenous bags. All unexpired lots of Oxytocin compounded with Lactated Ringers and all unexpired lots of Oxytocin compounded with Lactated Ringers and Dextrose are included in this recall. The product can be identified by referring to the sample labels provided. These products were distributed nationwide in the USA to hospitals/clinics.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

(Source: FDA)

Follow us on Twitter and Facebook for updates on the latest pharmaceutical and biopharmaceutical manufacturing news!

Related Articles Read More >

FDA logo
FDA prevented 317 drug shortages in 2021
Novartis logo
Novartis temporarily halts production of two radioligand therapy medicines
Capsules
Herbal supplements recalled as a result of undeclared sildenafil and tadalafil
Gilead Sciences
Gilead identifies counterfeit versions of two of its HIV drugs

DeviceTalks Tuesdays

DeviceTalks Tuesdays

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.

Need Pharmaceutical Processing news in a minute?

We Deliver!
Pharmaceutical Processing Enewsletters get you caught up on all the mission critical news you need. Sign up today.
Enews Signup
Pharmaceutical Processing World
  • Subscribe to Our Free E-Newsletter
  • Contact Us
  • About Us
  • Advertise With Us
  • R&D World
  • Drug Delivery Business News
  • Drug Discovery & Development
  • DeviceTalks
  • MassDevice
  • Medical Design & Outsourcing
  • MEDICAL TUBING + EXTRUSION
  • Medical Design Sourcing
  • Medtech100 Index

Copyright © 2022 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • R&D 100 Awards