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U.S. Department of Health and Human Services

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Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Qualitest Pharmaceuticals, Inc. Issues a Voluntary Nationwide Recall of Accusure Insulin Syringes 1cc 28 Gauge 1/2 Inch 100's

Contact:
Charles V. (Trey) Propst
1-800-444-4011

FOR IMMEDIATE RELEASE -- Huntsville, AL -- June 14, 2005 -- Qualitest Pharmaceuticals, Inc., today has issued a voluntary nationwide recall of Accusure Insulin Syringes 1cc, 28 Gauge l/2 Inch, distributed between October 2004 and June 2005. There may be 1cc syringes which are mislabeled as 1/2 cc syringes on the plastic inner wrap holding 10 individual syringes, which could potentially result in confusion by the patient or caregiver, resulting in an incorrect dose or amount being administered.

No injuries have been reported to date.

Consumers who have any of the product on hand should immediately stop using, and contact Qualitest, or return unused syringes to the pharmacy from which purchased.

Product was distributed to drug wholesalers/distributors, and pharmacies within the United States.

The product affected is as follows:

NDC 0603-6996-21 Accusure Insulin Syringes 1cc 28 Gauge 1/2 Inch Boxes of 100 (all lots)

Qualitest is notifying all customers who received the product and arranging for return of any affected product.

This recall is being conducted with the full knowledge of the Food and Drug Administration.

Consumers with questions may contact the company at 1-800-444-4011 for more information.

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