Signature Formulations, LLC: ORL Kids Mouthwash, Bubblegum Flavor, 16.9 oz. (500ml) per bottle, ORL Labs, LLC, Scottsdale, Arizona USA
Read the official notice at FDA (drug) →
The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.
- Company / brand
- Signature Formulations, LLC
- Product
- ORL Kids Mouthwash, Bubblegum Flavor, 16.9 oz. (500ml) per bottle, ORL Labs, LLC, Scottsdale, Arizona USA
- Reason / hazard
- cGMP Deviations
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- AZ only
- Recall initiated
- 2025-12-08
- Code info
- Lot #: 250505P9, Exp. Date 05/27
- Product quantity
- 570 bottles
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Phoenix
- State
- AZ
- Country
- United States
- Event id
- 98131
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