Dabur India Limited — Class II: Rapidol, Triple Antibiotic First Aid Ointment, Bacitracin Zinc 400 units, Neomycin Sulfate
Dabur India Limited has initiated a Class II recall of Rapidol Triple Antibiotic First Aid Ointment due to Current Good Manufacturing Practice (CGMP) deviations and deficiencies observed during an FDA inspection.
This recall affects Dabur India Limited, the distributor Pharmadel LLC, and pharmaceutical professionals involved in the quality oversight and distribution of topical antibiotic ointments manufactured in India for the US market.
The classification as a Class II recall suggests that while the health risk may not be immediate or severe, the CGMP deficiencies are significant enough to warrant a market withdrawal. This highlights the FDA's ongoing scrutiny of international manufacturing facilities and the requirement for adherence to quality standards regardless of the manufacturing location. The 'Ongoing' status indicates that the firm is still in the process of executing the recall and potentially remediating the underlying inspectional findings.
Quality teams should assess the GMP compliance status of offshore contract manufacturing partners. Regulatory departments should verify that imported OTC drug products meet all domestic manufacturing standards and that inspectional findings at the manufacturing site are addressed through formal CAPA processes to prevent supply chain disruptions during ongoing recalls.
Class II. Reason: CGMP Deviations; deficiencies observed during FDA inspection. Product: Rapidol, Triple Antibiotic First Aid Ointment, Bacitracin Zinc 400 units, Neomycin Sulfate 3.5 mg, Polymyxin-B Sulfate 5,000 units, net wt. 2oz (57g) tubes, Distributed by/por: Pharmadel LLC, New Castle, DE 19720, Made in India, UPC 8 10096 77162 9.. Firm: Dabur India Limited (Dadra And Nagar Haveli India). Status: Ongoing.
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