PRITAM INTERNATIONAL PRIVATE LIMITED — Class II: Brush Buddies, Crayola, Silly Scents, Anticavity Fluoride Toothpaste, (sodium fluoride0.24
Pritam International Private Limited has initiated an ongoing Class II recall for specific lots of Brush Buddies, Crayola, and Silly Scents Anticavity Fluoride Toothpaste due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects 4.0 oz tubes of Watermelon Flavor toothpaste (sodium fluoride 0.243%) distributed by Ashtel Studios Inc.
Manufacturers of OTC fluoride toothpaste, quality and compliance departments at international drug manufacturing sites, and distributors of pediatric oral care products.
A Class II recall due to CGMP deviations suggests that while the health hazard may not be immediate or severe, the manufacturing processes failed to meet regulatory standards for safety, identity, strength, quality, or purity. This indicates potential systemic issues at the manufacturing facility in India that could impact other products manufactured at the same site. Compliance teams should note the focus on fluoride-containing OTC drugs, which are subject to specific monograph requirements.
Review supplier qualification programs for international contract manufacturers and ensure site-specific CGMP compliance audits are current. Verify that all distributed OTC drug products, particularly those marketed for children, meet monograph requirements and documented manufacturing standards.
Class II. Reason: CGMP Deviations.. Product: Brush Buddies, Crayola, Silly Scents, Anticavity Fluoride Toothpaste, (sodium fluoride0.243%) Watermelon Flavor, Net Wt. 4.0 oz (113g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-004-40, Item # Product code: 32730, UPC 8 50048 32730 6.. Firm: PRITAM INTERNATIONAL PRIVATE LIMITED (Haridwar India). Status: Ongoing.
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