Dabur India Limited — Class II: Lucky Super Soft, First Aid Triple Antibiotic Ointment, Bacitracin zinc 400 units, neomyci
Dabur India Limited has initiated a Class II recall for Lucky Super Soft First Aid Triple Antibiotic Ointment due to CGMP deviations and deficiencies identified during an FDA inspection.
This recall affects Dabur India Limited, Delta Brands Inc., and entities involved in the distribution or retail of Lucky Super Soft Triple Antibiotic Ointment (UPC 8 08829 10372 4).
The classification as a Class II recall indicates that the CGMP deficiencies may lead to temporary or medically reversible adverse health consequences. This enforcement action highlights the FDA's focus on manufacturing standards for OTC topical products produced at international facilities. For regulatory professionals, this demonstrates the risk associated with supply chain oversight and the importance of pre-emptive vendor audits.
Quality teams should verify if any current inventory is sourced from this contract manufacturer. Compliance officers should review existing CGMP audit reports for overseas suppliers to ensure site-specific deficiencies regarding topical ointment production are addressed.
Class II. Reason: CGMP Deviations; deficiencies observed during FDA inspection. Product: Lucky Super Soft, First Aid Triple Antibiotic Ointment, Bacitracin zinc 400 units, neomycin sulphate 3.5 mg, polymyxin B sulphate 5000 units, Net Wt. 0.5 oz (14g) tubes, Manufactured for Delta Brands Inc., 580 White Plains Rd., Tarrytown, NY 10591 USA, Made in India, UPC 8 08829 10372 4.. Firm: Dabur India Limited (Dadra And Nagar Haveli India). Status: Ongoing.
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