PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: February 20, 2019 Initiated: December 18, 2018 #D-0486-2019

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.

Details

Recalling Firm
LGM Pharma LLC
Units Affected
205 grams
Distribution
Distributed to MS and Spain
Location
Erlanger, KY

Frequently Asked Questions

What product 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. Recalled by LGM Pharma LLC. Units affected: 205 grams.
Why was this product recalled?
CGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
Which agency issued this recall?
This recall was issued by the FDA Drug on February 20, 2019. Severity: Moderate. Recall number: D-0486-2019.