Luitpold temporarily suspends distribution of drug products manufactured at Shirley, New York facility

Apr 22 2011

Luitpold Pharmaceuticals, Inc. ("Luitpold") today announced that it has temporarily suspended distribution of all of its drug products manufactured at its Shirley, New York facility and marketed by its American Regent, Inc. subsidiary and Animal Health Division.  This action DOES NOT affect products manufactured at its PharmaForce Inc. subsidiary, including its Betamethasone Sodium Phosphate and Betamethasone Sodium Acetate Injectable Suspension, USP. Osteohealth and Regency Therapeutics Division products, including SPRIX® (Ketorolac Tromethamine) Nasal Spray are not affected.

As a result of a recent inspection and a follow-up meeting with FDA on April 14, 2011, Luitpold agreed to temporarily suspend distribution of any drug product manufactured at its Shirley, New York facility.  (It had previously suspended the manufacture of its drug products on its own initiative).

Luitpold is in the process of developing a plan, in conjunction with outside consultants and the FDA, that will allow it to resume manufacturing and distribution of its drug products as soon as possible.  Luitpold Pharmaceuticals, Inc. will provide further information on its estimated timetable to resume supply of products to the market in the near future.

Luitpold has communicated with the FDA Drug Shortage Staff regarding this issue, and will work with them to address potential shortages of drug products critical to patient health.  

Any questions concerning this notice should be directed to the American Regent Customer Service Department at 1-800-645-1706 or the Animal Health Division at 1-800-458-0163.