PRITAM INTERNATIONAL PRIVATE LIMITED — Class II: Brush Buddies, Mint Chocolate Chip Ice Cream Flavored Toothpaste, Anticavity Fluoride Toot
Pritam International Private Limited has initiated a Class II recall for Brush Buddies Mint Chocolate Chip Ice Cream Flavored Toothpaste (0.243% sodium fluoride) due to Current Good Manufacturing Practice (CGMP) deviations. The recall involves 3.5 oz units distributed by Ashtel Studios Inc. and remains ongoing.
This recall affects PRITAM INTERNATIONAL PRIVATE LIMITED, the distributor Ashtel Studios Inc., and regulatory/QA professionals responsible for overseeing OTC fluoride toothpaste manufacturing and supply chain compliance.
A Class II designation suggests that while the health hazard is not immediate or life-threatening, the CGMP deviations are significant enough to warrant a formal recall. This indicates potential systemic failures in the manufacturing process at the Haridwar, India facility. The involvement of a foreign manufacturer and a domestic distributor highlights the importance of robust oversight in international contract manufacturing arrangements for monograph drugs.
Quality teams should verify that contract manufacturing organizations (CMOs) maintain strict adherence to CGMP standards. Regulatory departments should review the compliance status of foreign suppliers and ensure that distribution partners are notified of ongoing enforcement actions involving specific NDC/UPC lots.
Class II. Reason: CGMP Deviations.. Product: Brush Buddies, Mint Chocolate Chip Ice Cream Flavored Toothpaste, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Net Wt. 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-520-35, Item # 88520, UPC 8 10147 88520 6. Firm: PRITAM INTERNATIONAL PRIVATE LIMITED (Haridwar India). Status: Ongoing.
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