December 20, 2019
Hospira Inc., a Pfizer company, is voluntarily recalling more than 77,000 syringes containing 25% dextrose injection. According to the December 18, 2019, US Food and Drug Administration (FDA) Enforcement Report, the expiration date printed on the syringes is wrong.
The recall affects 25% dextrose injection, 2.5 grams (250 mg/mL), 10-mL single-dose syringes (NDC 0409-1775-10) from lot 80-292-EV. The correct expiration date, which is listed on the carton, is August 1, 2019. The incorrect date listed on the syringe is August 1, 2021.
“The expiry on this product has been extended through FDA, and the extended use date is 1DEC2019,” Hospira clarified in a letter posted on the Pfizer website. “The potential risk to patients arising from this issue is considered to be negligible. To date, Hospira has not received any reports of adverse events associated with this lot.”
The recalled product was distributed within the United States and Puerto Rico.
Pfizer initiated the recall November 27, 2019. On December 6, 2019, the FDA designated the recall Class II, signaling use of the product could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.
Dextrose injection is a prescription treatment for low blood sugar.