PRITAM INTERNATIONAL PRIVATE LIMITED — Class II: Brush Buddies, My Little Pony Scents Anticavity Fluoride Toothpaste, (sodium fluoride 0.24
Pritam International Private Limited has initiated a Class II recall for Brush Buddies My Little Pony Scents Anticavity Fluoride Toothpaste due to CGMP deviations. The recall remains ongoing and affects products distributed by Ashtel Studios Inc.
This recall affects Pritam International Private Limited, the distributor Ashtel Studios Inc., and quality/regulatory professionals overseeing OTC drug manufacturing and international supply chains.
A Class II recall for CGMP deviations suggests that the FDA has identified manufacturing process deficiencies that could potentially cause temporary or medically reversible adverse health consequences. For firms utilizing international manufacturers, this highlights the necessity of robust oversight to ensure that facilities in all jurisdictions meet US regulatory standards for drug production.
Quality units should verify that contract manufacturing organizations (CMOs) maintain strict adherence to CGMP standards. Regulatory teams should monitor the status of ongoing recalls for potential impact on domestic distribution networks.
Class II. Reason: CGMP Deviations.. Product: Brush Buddies, My Little Pony Scents Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Bubble Gum Flavor, Net Wt. 4.0 oz (113g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-008-40, Item# 88270, UPC 8 10147 88270 0.. Firm: PRITAM INTERNATIONAL PRIVATE LIMITED (Haridwar India). Status: Ongoing.
Open in openFDA / FDA.gov