February 12, 2021
Lupin Pharmaceuticals Inc. has issued a voluntary recall for a single lot of oseltamivir phosphate for oral suspension after samples tested out of specification for an impurity. The recall was included in the February 10, 2021, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects 46,479 bottles of oseltamivir phosphate for oral suspension, 6 mg/mL, 60 mL (NDC 68180-678-01), from lot A906423 (Exp. 11/21). The product was distributed throughout the United States.
Lupin Pharmaceuticals initiated the recall January 21, 2021. On February 3, 2021, the FDA designated the recall Class III. Under the recall classification, use of the affected product is not likely to cause harm.
Oseltamivir is a prescription antiviral medication used to treat symptoms caused by the flu.