October 10, 2019
Alkermes Inc. is recalling more than 16,000 Vivitrol (naltrexone for extended-release injectable suspension) kits because of incorrect needle packaging, according to the October 9, 2019, US Food and Drug Administration (FDA) Enforcement Report.
The recall is “due to 1-inch needles being placed in the 1.5-inch needle cardboard sleeve labelled as administration needles,” the FDA report stated. “The product vial is not impacted.”
The recall is for Vivitrol kits containing 380 mg/vial (NDC 65757-300-01) from lots 2019-1002T and 2019-1003T (Exp. 5/21). The kits were distributed throughout the United States and Canada.
Alkermes voluntarily initiated the recall September 26, 2019. On October 2, 2019, the FDA designated the recall Class II, communicating use of the product may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm.
Vivitrol is a prescription injectable medication used to treat alcohol or opioid dependence.