FDA recall D-1508-2020

Lannett Company, Inc. · Class II · drug

Product

Prednisone Tablets, USP 2.5 mg, 100 tablets, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, Manufactured by: Tianjin Tianyao Pharmaceuticals Co., Ltd No. 221 Huanghai Road, Tianjin Economical-Technological Development Area, Tianjin, China 300457 NDC 0527-2931-37

Reason for recall

Labeling: Label Mix Up: bottle labeled to contain Prednisone Tablets, USP 2.5 mg actually contained Prednisone Tablets, USP 10 mg

Distribution

US Nationwide

Key facts

Status
Terminated
Initiation date
2020-08-10
Report date
2020-08-26
Termination date
2022-07-22
Voluntary/Mandated
Voluntary: Firm initiated
Location
Philadelphia, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1508-2020