Benzodiazepine Concentrate Recalled

Lannett Company Inc is recalling 23,598 bottles of diazepam oral solution (concentrate) for failing to meet impurity/degradation specifications, according to the February 23, 2022, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects diazepam oral solution (concentrate), 25 mg per 5 mL (5 mg/mL), in 30-mL bottles with dropper (NDC 0527-1768-36), from lots 2664A and 2664B (Exp. 7/22), and 2874A and 2874B (Exp. 1/23). The affected product was distributed throughout the United States.

Lannett Company voluntarily initiated the recall February 9, 2022. On February 14, 2022, the FDA designated the recall Class II. The classification communicates that use of the medication may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm.

Diazepam is a prescription benzodiazepine used to treat anxiety, alcohol withdrawal, seizures, and muscle spasms, as well as to provide sedation before medical procedures.