Medline Recalls SparkleFresh Toothpaste Due to Microbial Contamination
Medline Industries is recalling SparkleFresh fluoride toothpaste nationwide due to microbial contamination of the non-sterile product.
What this means for you
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. The source text identifies the hazard as microbial contamination of a non-sterile product but does not report specific illnesses, injuries, or hospitalizations, aligning with the 'Moderate' criteria for low-risk contamination or voluntary precautionary recalls without reported harm.
Plain-English summary
Medline Industries Inc. is recalling SparkleFresh Fluoride Toothpaste (Sodium Monofluorophosphate 0.76%) in various tube sizes (17 g, 24 g, and 42.5 g) due to microbial contamination. The affected product is a non-sterile dental product manufactured in Malaysia for Medline Industries, Inc.
The recall covers approximately 994,756 tubes distributed nationwide in the United States and Puerto Rico. Specific lot numbers and expiration dates are listed in the recall documentation, including lots expiring in October and November 2020.
Consumers who have purchased this product should stop using it and contact Medline Industries for a refund or replacement. The FDA classifies this as a Class II recall, indicating a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- SPARKLEFRESH (SODIUM MONOFLUOROPHOSPHATE)
- Brand
- SPARKLEFRESH
- Manufacturer
- Medline Industries Inc
- Category
- Drug — Dental / OTC
- Hazard
- Affected units
- 994,756
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 (9)
- a) Lot 102920C
- exp 10/29/2020 and 111220C
- exp 11/11/2020
- b) 111620D
- exp 11/16/2020
- c) 111420D
- exp 11/14/2020
- d) 111720C
- exp 11/17/2020
Distribution
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