Class I Recall Issued for Antiseizure Med

A labelling error misstating the product strength has prompted a Class I recall for 2770 infusion bags of levetiracetam in 0.54% sodium chloride injection, 1500 mg/100 mL (15 mg/mL), distributed throughout the United States by Dr. Reddy's Laboratories Inc. The recall was included in the February 20, 2019, US Food and Drug Administration (FDA) Enforcement Report stated.  

The FDA classification, issued February 11, 2019, suggests use of the affected product could cause serious adverse health consequences or death.

“The preprinted text on the primary infusion bag and the NDC incorrectly identifies the product as levetiracetam in 0.75% sodium chloride (1000 mg/100 mL),” the FDA explained in the recall report. “However, the external foil pouch correctly identifies the product as levetiracetam in 0.54% sodium chloride injection (1500 mg/100 mL).”

The recall affects levetiracetam in sodium chloride infusion bags manufactured by Gland Pharma Limited from lot ABD807 (Exp. 5/20). Dr. Reddy's Laboratories voluntarily initiated the recall October 26, 2018. 

Levetiracetam infusion bags are used in the treatment of seizures when oral administration is not possible.  

—Jolynn Tumolo