CIDOFOVIR DIHYDRATE, (Non-Sterile, For Manufacturing Use), 10g, Rx only, ALP PHARM BEIJING CO., L...
FDA Recall #D-0486-2019 — Class II — December 18, 2018
Product Description
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.
Recalling Firm
LGM Pharma LLC — Erlanger, KY
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
205 grams
Distribution
Distributed to MS and Spain
Code Information
Lot number: JD-BP-37-20150801
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated