FDA recall D-0429-2025

KENIL HEALTHCARE PRIVATE LIMITED · Class II · drug

Product

Rapidol, Triple Antibiotic First Aid Ointment, Bacitracin Zinc/ Neomycin Sulfate/ Polymyxin B Sulfate, Net Wt 2 oz (56g) Tube, Distributed by: Pharmadel LLC, New Castle, DE, 19720, Made in India, NDC 55758-440-02, UPC 8 10096 77162 9.

Reason for recall

CGMP Deviations

Distribution

DE and NC

Key facts

Status: Terminated
Initiation date: 2025-04-24
Report date: 2025-05-28
Termination date: 2026-02-19
Voluntary/Mandated: Voluntary: Firm initiated
Location: Ta. Kadi, District Mehsana, N/A, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0429-2025