On June 5, 2012, JHP Pharmaceuticals, LLC initiated a Class III recall of Pitocin (Oxytocin Injection, USP), 10 units per mL, 10 mL vials, NDC 42023-116-02.
The recall affected lot 225867 and part of lot 231423. The reason cited was a labeling mix-up regarding storage conditions.
According to the recall record, the label should have read "Store between 20 to 25 degrees C (68 to 77 degrees F)." Instead, the affected labels read "Store between 20 to 25 degrees C (28 to 77 degrees F)."
The FDA classified this action as Class III. This classification is assigned to situations that are unlikely to cause adverse health consequences.
The recall status is listed as terminated. No additional details on health outcomes or corrective actions beyond the labeling correction were included in the event record.
This event pertains specifically to a labeling discrepancy on affected Pitocin lots and does not indicate a broader safety concern with oxytocin as an approved product.
For more background on this compound, readers can consult the oxytocin overview page.