August 2018 FDA Recall Drug by Alkano Chemicals, Inc
D-0008-2019 - CGMP Deviations

This Class II drug recall was voluntarily initiated by Alkano Chemicals, Inc on August 30, 2018 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in Distributed to two compounding firms in Minnesota. and the recall is currently terminated.

Recall Number: D-0008-2019

Reason for Recall
CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
Initiated
08-30-2018
Reported
10-17-2018
Quantity
8 kgs

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81147
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Alkano Chemicals, Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed to two compounding firms in Minnesota.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-21-2019
Product Description About Product Description
Full technical description of the product.
Thyroid powder, 4.5 kg foil bag, 5x1 kg foil bags packed in 25 Kg Fiber Drum, Thyroid Powder 25kg/drum, US Pharmacopoeia, Sichuan Friendly Pharmaceutical Co., LTD, Production Address: No. 680, Hongpai Road, Dongxing District, Neijiang City Sichuan, China Tel:+886 832 2240082/2240298, NDC 7807-0170-11

Batch or Lot Expiration Information

Lot# 170501