The recall of Ofirmev lot number V005710 was initiated due to the presence of an unidentified, visible particle in one vial of this lot during routine stability testing.
The company has undertaken the recall as a precautionary measure.
No reports of adverse patient events associated with particulate matter in the product were received by the company.
The FDA has been notified of the recall.
Cadence chief commercial officer Scott Byrd said they were successful in their efforts to accelerate shipments of Ofirmev from another supplier, which allowed them to resume normal shipments.