April 15, 2011
RECALL: Teva's Lansoprazole Delayed-Release Orally Disintegrating Tablets WithdrawnTeva Pharmaceuticals has voluntarily withdrawn its lansoprazole delayed-release orally disintegrating tablets (ODT) product from distribution after the FDA received reports of clogged and blocked oral syringes and feeding tubes when the drug is administered as a suspension through these devices. The tablets may not fully disintegrate when water is added to them and/or they may disintegrate but later form clumps that can adhere to the inside walls of oral syringes and feeding tubes. Some patients have had to seek emergency medical assistance and feeding tubes have had to be unclogged or removed and replaced.
The FDA recommends that healthcare professionals evaluate their medication stock and not dispense or administer the product to patients who take the drug through an oral syringe or feeding tube. Patients and caregivers should be instructed not to administer the Teva lansoprazole delayed-release ODT product through oral syringes and/or feeding tubes due to the potential for clogging and blockage of the oral syringe or tube. No problems have been reported with patients who take the product by mouth.
Lansoprazole is a proton pump inhibitor (PPI) medication. It is approved for the treatment of gastric and duodenal ulcers, gastroesophageal reflux disease (GERD), erosive esophagitis, and Zollinger-Ellison Syndrome.
For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm251575.htm.