February 2020 FDA Recall Drug by Sunstar Guangzhou Ltd.
D-0997-2020 - cGMP Deviation

This Class II drug recall was voluntarily initiated by Sunstar Guangzhou Ltd. on February 28, 2020 for the product Drug. The FDA reported the reason for recall as cgmp deviation. The product was distributed in Florida only and the recall is currently terminated.

Recall Number: D-0997-2020

Reason for Recall
cGMP Deviation
Initiated
02-28-2020
Reported
03-18-2020
Quantity
260,000 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85127
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.
Sunstar Guangzhou Ltd.
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.
Florida only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-29-2021
Product Description About Product Description
Full technical description of the product.
Sunstar GUM Toothpaste 3 g tubes, Toothpaste made in Japan, packed in China, NDC 53050-0002-01

Batch or Lot Expiration Information

Lot# : 20180621 Exp. 2020-06-21, 20180827 Exp. 2020-08-27, 20190115 Exp. 2021-01-15