August 2018 FDA Recall Drug by Lgm Pharma Llc
D-0296-2019 - CGMP Deviations
This Class II drug recall was voluntarily initiated by Lgm Pharma Llc on August 24, 2018 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0296-2019
CGMP Deviations: Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
08-24-2018
12-19-2018
1,307 kg
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
09-11-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Thyroid Powder, USP, 25kg/drum, Rx Only, Sichuan Friendly Pharmaceutical Co., LTD. NDC: 070870-1701-1
Batch or Lot Expiration Information
Lot# Lots: 161101, EXP 11/2/2016; 161201, EXP Nov 2018; 170301, EXP Feb 2019; 170501, Exp Apr 2019; 170701, Exp Jun 2019
