Dabur India Limited — Class II: Med Pride, Triple Antibiotic Ointment, Bacitracin Zinc (equivalent to 400 units), Neomycin
Dabur India Limited has initiated a Class II recall for Med Pride Triple Antibiotic Ointment due to cGMP deviations and deficiencies observed during an FDA inspection. The recall is currently listed as ongoing and affects various sizes including 0.9g packets and 130g units.
This affects Dabur India Limited, Shield Line LLC, and quality/regulatory personnel involved in the distribution and oversight of topical OTC antibiotic ointments manufactured in India.
A Class II recall due to cGMP deviations suggests that the FDA identified systemic issues in the manufacturing process that could potentially lead to temporary or reversible adverse health consequences. This underscores the regulatory risk for distributors (like Shield Line LLC) relying on international manufacturing partners whose facilities fail to meet FDA-mandated quality standards.
QA teams should verify if any current inventory is sourced from this contract manufacturer. Regulatory departments should review recent inspection results for overseas manufacturers and ensure that cGMP compliance documentation is up to date for all distributed products.
Class II. Reason: CGMP Deviations; deficiencies observed during FDA inspection. Product: Med Pride, Triple Antibiotic Ointment, Bacitracin Zinc (equivalent to 400 units), Neomycin Sulfate 5 mg, Polymixin B 5000 units, 0.9g packets, 144 packets per box, 130g, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 1 03 52410 30253 1.. Firm: Dabur India Limited (Dadra And Nagar Haveli India). Status: Ongoing.
Open in openFDA / FDA.gov