Sunstar GUM Toothpaste Recalled for cGMP Deviation in Florida
Sunstar Guangzhou Ltd. is voluntarily recalling 260,000 tubes of GUM Toothpaste in Florida due to a cGMP deviation. The recall was initiated in February 2020.
The agency’s classification
FDA (Drugs): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The source cites a cGMP deviation without specific reports of illness or injury, fitting the Moderate category for voluntary precautionary recalls or minor labeling/process errors.
Plain-English summary
Sunstar Guangzhou Ltd. is voluntarily recalling 260,000 tubes of Sunstar GUM Toothpaste, 3 g tubes, NDC 53050-0002-01. The product was made in Japan and packed in China. The recall was initiated on February 28, 2020, and is classified as Class II by the FDA.
The reason for the recall is a cGMP (current Good Manufacturing Practice) deviation. The affected lots are 20180621 (Exp. 2020-06-21), 20180827 (Exp. 2020-08-27), and 20190115 (Exp. 2021-01-15). The distribution was limited to Florida only.
Consumers who have these products should stop using them and follow the instructions provided by the recalling firm. The recall status is currently terminated as of March 29, 2021.
The recalled product
- Product
- Sunstar GUM Toothpaste 3 g tubes, Toothpaste made in Japan, packed in China, NDC 53050-0002-01
- Manufacturer
- Sunstar Guangzhou Ltd.
- Category
- Drug — Oral Care
- Hazard
- Affected units
- 260,000
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot #: 20180621 Exp. 2020-06-21
- 20180827 Exp. 2020-08-27
- 20190115 Exp. 2021-01-15
Distribution
Distributed in 1 state:
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