ARU Toothpaste Recalled for CGMP Deviations
Pritam International is voluntarily recalling 15,264 tubes of ARU Toothpaste due to Current Good Manufacturing Practice (CGMP) deviations.
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 Class II due to CGMP deviations, and the source does not report any illnesses, injuries, or deaths.
Plain-English summary
Pritam International Private Limited is voluntarily recalling 15,264 tubes of ARU Toothpaste, Gum Health, 9 Ingredients, Soothing Mint. The product is distributed by Ashtel Studios Inc. and was sold nationwide in the United States.
The recall was initiated because of Current Good Manufacturing Practice (CGMP) deviations. The affected product includes two specific lots: Lot # LWP250047850611D with an expiration date of 12/23/2027, and Lot # LWP260052612201D with an expiration date of 04/30/2028.
The source text does not report any illnesses, injuries, or deaths associated with this product. Consumers should check their inventory for the specific lot numbers and expiration dates listed above.
The recalled product
- Product
- ARU, Toothpaste, Gum Health, 9 Ingredients, Soothing Mint, (stannous fluoride 0.45%) Net Wt 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-786-35, Item # 88786 UPC 8 10147 88786 6
- Manufacturer
- PRITAM INTERNATIONAL PRIVATE LIMITED
- Category
- Drug — Dental
- Hazard
- Affected units
- 15,264
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 (4)
- Lot # LWP250047850611D
- Exp Date: 12/23/2027
- Lot # LWP260052612201D
- Exp Date: 04/30/2028.
Distribution
Distributed nationwide across the United States.
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