Practitioners' Reporting News

Ivax Pharmaceuticals, Inc. Revises Labeling for Teargen II Lubricant Eye Drops

Issued December 21, 2005

In response to a report submitted through the USP Medication Errors Reporting (MER) Program, Ivax Pharmaceuticals, Inc., has changed the labeling of Teargen II Lubricant Eye Drops distributed by Goldline Laboratories, Inc. The potential for error lies in the fact that while the outer carton lists the active ingredients, the bottle does not. The active ingredient of this product is hypromellose (hydroxypropyl methylcellulose) an ophthalmic agent used to relieve dryness and irritation. The reporter's concern was that the omission of the active ingredient from the label of the bottle would make it difficult for nurses to verify the medication against the physician's order.

The revised container labeling which will be available for distribution by the end of December 2005, now clearly states the active ingredient in the Drug Facts section.

Old Labeling	New Labeling