PRITAM INTERNATIONAL PRIVATE LIMITED — Class II: evo, Sensitive, Anticavity Fluoride Toothpaste, (potassium nitrate 5%, sodium fluoride 0.2
Pritam International Private Limited has initiated an ongoing Class II recall for 'evo Sensitive Anticavity Fluoride Toothpaste' due to CGMP deviations. The recall affects the 3.5 oz Sweet Mint variant distributed by Ashtel Studios Inc.
This recall affects the manufacturer (Pritam International), the distributor (Ashtel Studios Inc.), and quality assurance professionals managing OTC drug product compliance.
A Class II recall due to CGMP deviations suggests that the FDA has identified systemic manufacturing issues that could potentially cause temporary or medically reversible adverse health consequences. For firms utilizing international contract manufacturers for OTC monographs, this highlights the necessity of robust oversight and adherence to US manufacturing standards regardless of the production site's location.
Conduct a review of contract manufacturing partner CGMP compliance, specifically for monograph-regulated OTC products. Verify that documentation for sensitive toothpaste formulations meets current quality standards to mitigate risks of cross-contamination or potency issues.
Class II. Reason: CGMP Deviations.. Product: evo, Sensitive, Anticavity Fluoride Toothpaste, (potassium nitrate 5%, sodium fluoride 0.24%) Sweet Mint, Net Wt. 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-620-35, Item # 88620 UPC8 10147 88620 3. Firm: PRITAM INTERNATIONAL PRIVATE LIMITED (Haridwar India). Status: Ongoing.
Open in openFDA / FDA.gov