2011-04-18 17:35:37 UTC

Teva Pulls Acid Reflux Tablets

April 22, 2011

The FDA has received reports that Teva’s lansoprazole delayed-release orally disintegrating tablet has clogged and blocked oral syringes and feeding tubes, including both gastric and jejunostomy types, when the drug is administered as a suspension through these devices.

The FDA has received reports that Teva’s lansoprazole delayed-release orally disintegrating tablet (ODT) has clogged and blocked oral syringes and feeding tubes, including both gastric and jejunostomy types, 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. These clumps can adhere to the inside walls of oral syringes and feeding tubes. In some cases, patients have had to seek emergency medical assistance and their feeding tubes have had to be unclogged or removed and replaced.

Lansoprazole is a PPI medication approved for the treatment of gastric and duodenal ulcers, GERD, erosive esophagitis and Zollinger-Ellison Syndrome.

Teva Pharmaceuticals has voluntarily withdrawn its lansoprazole delayed-release ODT product from distribution at this time. However, some product may remain in stock in pharmacies and other facilities, and some patients may still have the product in their possession. The product may also be sold under the following labels: Sharp Corporation, Cardinal Health and Quality Packaging Specialist, Inc.

Learn more.

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