American Regent in Shirley, NY, is again hearing the hum of production and shipping activities in its injectables business, resuming shipments last week of such multisource products as Venofer (iron sucrose injection). The company is working with the FDA drug shortage staff to prioritize critical medications. Twenty products have been released and shipped so far, according to an announcement.
The shipping follows an investigation into glass delamination prompted by several product recalls. The company suspended production at the plant, reports in-Pharma Technologist.
The company says it can confirm the products now being shipped were manufactured in accordance with cGMP requirements. "American Regent is confident in the integrity and quality of these injectable products," according to the announcement.
Separately, the company initiated a recall of one lot of caffeine & sodium benzoate injection. Some vials may contain visible particles.