ReliOn insulin syringes, sold only at Wal-Mart stores and Sam’s Clubs, have been recalled because of mislabeling which may cause an overdose of as much as 2.5 times the intended dose. An overdose may lead to hypoglycemia or other serious health consequences, including death. One adverse incident relating to the recalled lot has been reported.
Tyco Healthcare Group LP (Covidien) is recalling lot number 813900, ReliOn 1cc, 31-guage, 100 units for use with U-100 insulin. These are sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles. Can-Am Care Corp distributed 4,710 boxes, which amount to 471,000 individual syringes, from August 1, 2008 to October 8, 2008 to Wal-Mart stores and Sam’s Clubs.
During packaging, some syringes labeled for use with U-40 insulin were mixed with syringes labeled for use with U-100 insulin, and then packaged individually in boxes as 100 units for use with U-100 insulin. The recall on October 9, 2008 by Tyco Healthcare Group LP (Covidien) was voluntary, and Wal-Mart stores and Sam’s Clubs posted the announcement as well as sent notification letters to more than 165,000 customers to return the recalled syringes to their local Wal-Mart or Sam’s Club pharmacy. The manufacturer will provide a replacement product
The FDA urges both patients and health care professionals to check their syringe packaging carefully before use.