Qualitest Pharmaceuticals Issues a Voluntary Nationwide Recall of All Accusure® Insulin Syringes

Tuesday, October 27th, 2009

- October 27, 2009 - Huntsville AL-Qualitest Pharmaceuticals today issued a voluntary nationwide recall of all AccusureŽ Insulin Syringes. The distributed syringes are of the following descriptions and NDC numbers: 28G 1/2cc, NDC 0603-6995-21;28G 1cc, NDC 0603-6996-21; 29G 1/2cc NDC 0603-6997-21, 29G 1cc, NDC 0603-6998-21, 30G 1/2cc, NDC 0603-999-21, 30G 1cc, NDC 0603-7000-21, 31G 1/2cc, NDC 0603-7001-21; and 31G 1cc, NDC 0603-7002-21. All AccusureŽ Insulin Syringes regardless of lot number are subject to this recall. These syringes were distributed between January 2002 and October 2009 to wholesale and retail pharmacies nationwide (including Puerto Rico). The syringes in these lots may have needles which detach from the syringe.

If the needle becomes detached from the syringe during use, it can become stuck in the insulin vial, push back into to the syringe, or remain in the skin after injection.

Consumers who have any AccusureŽ Insulin Syringes should stop using them and contact Qualitest at 1-800-444-4011 for reimbursement. You can find the lot number on the white paper backing of each individual syringe.

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

The recall is being made with the knowledge of the Food and Drug Administration.

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

Adverse reactions or quality problems experienced with the use of this product may be reported to FDA's MedWatch Adverse Event Reporting program either on line, by regular mail or by fax.

• Online:www.fda.gov/medwatch/report.htm
• Regular Mail: Use postage-paid FDA form 3500 available at: www.fda.gov/medwatch/getforms.htm
  Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
• Fax: 1-800-FDA-0178