FDA recall D-0558-2022

Product

Diazepam Oral Solution (Concentrate), 25 mg per 5 mL (5 mg/mL), 30 mL BOTTLE and DROPPER, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1768-36.

Reason for recall

Failed Impurities/Degradation Specifications: Out of specification results for related substances.

Distribution

Product was distributed nationwide in the USA.

Key facts

Status

Terminated

Initiation date

2022-02-09

Report date

2022-02-23

Termination date

2023-05-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Philadelphia, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0558-2022