FDA recall D-0486-2019

LGM Pharma LLC · Class II · drug

Product

CIDOFOVIR DIHYDRATE, (Non-Sterile, For Manufacturing Use), 10g, Rx only, ALP PHARM BEIJING CO., LTD, 12-2-620, Jia 69, Fushi Rd., Haidian, Beijing 100049, China. Batch Number JD-BP-37-20150801

Reason for recall

CGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.

Distribution

Distributed to MS and Spain

Key facts

Status: Terminated
Initiation date: 2018-12-18
Report date: 2019-02-20
Termination date: 2023-06-09
Voluntary/Mandated: Voluntary: Firm initiated
Location: Erlanger, KY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0486-2019