PharMEDium Services LLC is recalling all unexpired lots of Oxytocin compounded with Lactated Ringers and all unexpired lots of Oxytocin compounded with Lactated Ringers and Dextrose because laboratory tests show that there is a lower than expected potency on certain lots of the products, which would cause a lower dose being administered. To date, PharMEDium has received four reports of product complaints related to this issue.
Oxytocin is used to start or strengthen labor contractions during childbirth, and control bleeding after childbirth. It can also be used to induce abortion. Oxytocin is titrated based on clinical response, but an extreme and unexpected reduction in dose could lead to a delay in treatment, disruption of clinical care of the patient, and worsening of a patient’s conditions.
Affected Oxytocin compounded with Lactated Ringers and Oxytocin compounded with Lactated Ringers and Dextrose are packaged in ready-to-use intravenous bags. All unexpired lots of these products manufactured by PharMEDium are included in the recall. These products were distributed nationwide in the U.S. to hospitals and medical clinics.
PharMEDium is notifying customers of the recall by phone and instructing them to immediately quarantine the product, discontinue use and destroy it. Specific lots numbers can be identified at the company’s website at www.pharmedium.com.
Patients who have experienced any problems that may be related to these recalled products should consult their doctors. Any adverse events should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
Source: FDA Recall Notice