PRITAM INTERNATIONAL PRIVATE LIMITED — Class II: BB (Brush Buddies) Advanced Whitening, Anti-Cavity Fluoride Toothpaste, (sodium fluoride 0
Pritam International Private Limited has initiated an ongoing Class II recall for BB (Brush Buddies) Advanced Whitening, Anti-Cavity Fluoride Toothpaste due to CGMP deviations. The recall affects 3.5 oz units of sodium fluoride 0.24% toothpaste distributed by Ashtel Studios Inc.
This affects PRITAM INTERNATIONAL PRIVATE LIMITED, distributors of the Brush Buddies brand (Ashtel Studios Inc.), and QA/Manufacturing personnel involved in OTC drug production and oversight.
A Class II recall due to Current Good Manufacturing Practice (CGMP) deviations suggests that the FDA has identified systemic failures in the manufacturing process that may compromise product quality or consistency. For firms utilizing international contract manufacturers, this highlights the necessity of robust quality agreements and regular site audits to ensure adherence to regulatory standards.
Quality teams should evaluate supplier compliance for contract-manufactured OTC products, specifically focusing on CGMP alignment at international sites. Procurement and regulatory departments should verify the status of NDC 84140-885-42 within their inventory and pause distribution if applicable.
Class II. Reason: CGMP Deviations.. Product: BB (Brush Buddies) Advanced Whitening, Anti-Cavity Fluoride Toothpaste, (sodium fluoride 0,24%) Peppermint, Net Wt 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-885-42, Item # 88542, UPC 8 10147 88542 8. Firm: PRITAM INTERNATIONAL PRIVATE LIMITED (Haridwar India). Status: Ongoing.
Open in openFDA / FDA.gov