Safety Alerts & Recalls

What does this mean?

If you or someone you care for take lansoprazole tablets or capsules or Prevacid capsules by mouth, this alert does not affect your medicine supply and you can continue to take the medicine as directed. If you or someone you care for currently takes lansoprazole tablets through an oral syringe and/or feeding tube, please check to see if your supply is the Teva lansoprazole delayed-release ODT product. If your supply is from Teva or you do not know who makes your medicine, please contact your pharmacist or other healthcare professional to have your medicine examined and possibly replaced.

In general, the FDA also reminds patients and caregivers to closely follow the directions contained in medication product labels when administering any medicine through an oral syringe or feeding tube.

Healthcare professionals and patients are encouraged to report adverse events or side effects from medications to the FDA's MedWatch Program by telephone at 1-800-332-1088, by fax at 1-800-332-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

Lansoprazole Delayed-Release Orally Disintegrating Tablets by Teva Pharmaceuticals: Can Clog, Block Oral Syringes and Feeding Tubes

The U.S. Food and Drug Administration (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 stick 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.

Teva Pharmaceuticals has voluntarily withdrawn its lansoprazole delayed-release ODT product from distribution at this time. However, some Teva product may remain 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.

No problems have been reported with patients who take lansoprazole tablets or capsules or Prevacid capsules by mouth.

Lansoprazole is a proton pump inhibitor (PPI) medication. Lansoprazole is also known by the brand name Prevacid. It is approved for the treatment of gastric and duodenal ulcers, gastroesophageal reflux disease (GERD), erosive esophagitis (EE), and Zollinger-Ellison Syndrome (a condition involving overproduction of stomach acid). Lansoprazole delayed-release ODT products will still be available from other manufacturers. The FDA is recommending that patients receiving lansoprazole through oral syringes or feeding tubes should be dispensed a lansoprazole delayed-release ODT product from another manufacturer and should follow the specific directions in that product’s label for administration through an oral syringe or feeding tube.

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Source: FDA
Publication Date: 2011-04-19
Last Updated: 2011-04-19

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