The voluntary recall covers all Accusure syringes shipped to both wholesale and retail pharmacies in the US between January 2002 and October this year and amounts to an estimated 250m products.
The Food and Drug Administration (FDA), which has been informed of the problem, explained that the detached needles “can become stuck in the insulin vial, push back into to the syringe, or remain in the skin after injection.
Carole Ben-Maimon, senior VP of corporate strategy at Alabama-based Qualitest, told the Associated Press that the firm has received four reports of the detachment problem but no reports of injury.
Dr Ben-Maimon said that the recall, announced yesterday, expands on one issued on August 24 that covered two batches, lot numbers 6JCB1 and 7CPT1, shipped between January 2007 and June 2008.
Ben-Maimon explained that the wider recall was initiated after one of the reports that Qualitest received linked the detachment problem to products not covered by the original notification.
She also said that the affected syringes were supplied to Qualitest by a number of manufacturers.
Qualitest operates three manufacturing facilities, including two that are focused on the production and packaging of solid dose products in Charlotte, North Carolina and Huntville, Alabama.
The firm’s other production facility, a 161,000 sqft plant also located in Huntsville, makes and packs liquid and other soft generic pharmaceutical products.
The recalled 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.