Recall of Oxytocin Products Due to Lower than Expected Potency
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.
Laboratory test results have indicated a lower than expected potency affecting certain lots which would lead to a lower dose being administered. An unexpected reduction in dose could lead to a delay in treatment, disruption of clinical care of the patient, and worsening of patient's conditions.
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; (2) stimulation or reinforcement of labor, as in selected cases of uterine inertia; and (3) as adjunctive therapy in the management of incomplete or inevitable abortion.
The products were packaged in ready-to-use intravenous bags and were distributed nationwide to hospitals and clinics. All unexpired lots are included in this recall.
To date, the Company has received four reports of product complaints. Clinicians with questions regarding this recall can contact PharMEDium Services Clinical Pharmacist at (847) 457-2220. Adverse reactions or quality problems related to these products may be reported to the FDA's MedWatch Adverse Event Reporting program.
For more information visit Pharmedium.com.