December 2018 FDA Recall Drug by Lgm Pharma Llc
D-0486-2019 - CGMP Deviations
This Class II drug recall was voluntarily initiated by Lgm Pharma Llc on December 18, 2018 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in Distributed to MS and Spain and the recall is currently terminated.
Recall Number: D-0486-2019
CGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
12-18-2018
02-20-2019
205 grams
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
LGM Pharma LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Distributed to MS and Spain
06-09-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# Lot number: JD-BP-37-20150801
