FDA-Drug2022-02-23Class II

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.

Lannett Company, Inc.
Hazard

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

Sold states
Product was distributed nationwide in the USA.
Affected count
23,598 bottles
Manufactured in
9000 State Rd, N/A, Philadelphia, PA, United States
Products
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.

Official notice

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

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