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American Regent, one of the largest manufacturers of injectable medications is suspending all production of Phenylephrine HCI injection of 10mL, 5mL, and 1mL vials and has no estimate of a release date at this time.
On April 25, 2011, FDA reported that two drug manufacturers of Phenylephrine (Baxter and Sandoz) are also experiencing a delay in production of the drug as a result of the recent change in market requirements.
Due to American Regent’s suspension of Phenylephrine production, Baxter manufacturer is experiencing a backorder delay on 1 mL and 10mL vials of Phenylephrine HCI injection drug. However, Baxter has accelerated production and anticipates having Phenylephrine available in mid May. Additional lots are scheduled for manufacturing and are anticipated to be available for distribution in the June – July timeframe.
Sandoz is also experiencing a backorder of 10 mL and 5 mL vials of Phenylephrine HCI injection as the current market demand is more than the company’s current inventory can meet. Sandoz anticipates increased product availability by the end of May.
ASA has been informed that Luitpold Pharmaceuticals, the parent company of American Regent Manufacturer, is in the process of developing a plan, in conjunction with the FDA that will allow it to resume manufacturing and distribution of its American Regent Drug products as soon as possible.
