Children's mouthwash recalled over current good manufacturing practice deviations
Signature Formulations is recalling 570 bottles of ORL Kids Mouthwash, bubblegum flavour, over current good manufacturing practice 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: Scored 2 because the record cites current good manufacturing practice deviations with no stated product defect or reported harm.
Plain-English summary
ORL Kids Mouthwash, bubblegum flavour, 16.9 oz (500ml) per bottle, from ORL Labs, LLC of Scottsdale, Arizona, is being recalled by Signature Formulations, LLC.
The reason given in the enforcement record is cGMP deviations.
The recall covers 570 bottles from lot 250505P9, expiry 05/27. Distribution was in Arizona only. The FDA has classified the action as Class II.
The record cites manufacturing practice deviations without describing a specific product defect, and states no injuries. Consumers should follow the firm's instructions.
The recalled product
- Product
- ORL Kids Mouthwash, Bubblegum Flavor, 16.9 oz. (500ml) per bottle, ORL Labs, LLC, Scottsdale, Arizona USA
- Manufacturer
- Signature Formulations, LLC
- Category
- Drug — Oral care
- Affected units
- 570
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 (2)
- Lot #: 250505P9
- Exp. Date 05/27
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 2 recalled by Signature Formulations, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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