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Qualitest recalls all Accusure insulin syringes from US market due to needle problem

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Wednesday, October 28, 2009, 16:54 This news item was posted in medical devices category and has 0 Comments so far.

Accusure insulin syringes supplied by Qualitest Pharmaceuticals have been recalled from market in US, due to a mechanical snag which causes the needles detach from the synringe.

Qualitest Pharmaceuticals issued a voluntary nationwide recall of all Accusure insulin syringes.

Qualitest Pharmaceuticals is recalling about 250 million Accusure insulin syringes it has distributed nationwide since January 2002 because the products’ needles could detach from the syringes.

Accusure insulin syringes are ditributed in 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 Accusure insulin syringes regardless of lot have been recalled from the market .

Accusure insulin syringes were distributed between January 2002 and October 2009 to wholesale and retail pharmacies nationwide (including Puerto Rico).

Accusure insulin 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 Accusure Insulin Syringes should stop using them and contact Qualitest at 1-800-444-4011 for reimbursement, US FDA warned in a press release.

Consumers can find the lot number on the white paper backing of each individual Accusure insulin syringe.

Qualitest is notifying all customers who received Accusure insulin 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.

Huntsville AL based Qualitest provides over 600 generic pharmaceuticals. Qualitest is now ranked in the top ten among all suppliers of generics, based on total prescriptions filled.

As of November 5, 2007, funds advised by Apax Partners Worldwide LLP, a leading global private equity firm, acquired Qualitest Pharmaceuticals.

Qualitest’s range of prescription and over-the-counter products comprises tablets, capsules, liquids, suspensions, creams, and ointments. These are used to treat a wide variety of therapeutic categories, including antihypertensives, analgesics, antibiotics, cough/cold, antidepressants, antipsychotics, and others. Consumers find our products at all major retailers, as well as locally owned and operated pharmacies.

Qualitest Pharmaceuticals has four state of the art facilities, three in Huntsville, AL and one in Charlotte, NC. The first of the Huntsville facilities is a 161,000 square foot ultra modern facility for the manufacturing and packaging of liquids and other soft products complete with labs for QC and R & D. The second building is a 280,000 square foot manufacturing and packaging plant for solid dose products, also complete with QC and R & D labs. The third building weighs in at over 300,000 square feet and houses corporate offices and a distribution facility that is fully equipped with the newest automated shipping systems available.

Qualitest’s Charlotte facility is a 65,000 square foot solid dose manufacturing facility. State of the art, high velocity equipment has been installed in manufacturing and packaging. This facility also includes laboratory space for QC and R & D.

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