CIDOFOVIR DIHYDRATE recalled over sterility concerns

Recall date

December 18, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

LGM Pharma LLC recalls CIDOFOVIR DIHYDRATE, (Non-Sterile, For Manufacturing Use), 10g, Rx only, ALP PHARM BEIJING CO., LTD, 12-2-620, Jia 69,…

Recall number

D-0486-2019

FDA classification

Class II

Brand / firm

LGM Pharma LLC

Sold / distributed

Distributed to MS and Spain

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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