The US Food and Drug Administration is alerting doctors and
patients that Tyco Healthcare Group (Covidien) is recalling 4,710 boxes of
insulin syringes – with 100 syringes in each box – that were sold at Wal-Mart
and Sam’s Club from August 1, 2008 through October 8, 2008.
The syringes recall is due to possible mislabeling and
overdose risk. Their use “may lead to patients receiving an overdose of as much
as 2.5 times the intended dose, which may lead to hypoglycemia, serious health
consequences, and even death,” the FDA said in a statement.
The agency says some syringes labeled for use with U-40
insulin got packaged with syringes for U-100 insulin.
The recall applies to ReliOn Insulin Syringes (31 gauge 1
cc) from lot number 813900 having product identification number 38396-0403-02. The
number can be found on the top panel upper right-hand corner of the syringe
box. The FDA said the manufacturer has already received one adverse report
related to a syringe from this lot.
A recall announcement was posted in Wal-Mart stores and
Sam’s Clubs as well as on Wal-Mart website. Moreover, the company sent letters
to more than 16,500 customers notifying them of the recall.
Anyone having the recalled product is invited to contact Covidien
at 866-780-5436 or www.relion.com/recall
for more information. Customers bringing it back will be provided with a
replacement package.
Also, consumers may report any side effects resulting from using the recalled syringes to the FDA’s MedWatch program.