Recalls / Class II
Class IID-0429-2025
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.
- Brand name
- Rapidol
- Generic name
- Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate
- Active ingredients
- Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate
- Route
- Topical
- NDC
- 55758-440
- FDA application
- M004
- Affected lot / code info
- Lot SP27A, Exp: 09/30/2026
Why it was recalled
CGMP Deviations
Recalling firm
- Firm
- KENIL HEALTHCARE PRIVATE LIMITED
- Manufacturer
- Pharmadel LLC
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- Plot 319, Village Acharasan, Ankhol-Vamaj Road, Ta. Kadi, District Mehsana, N/A N/A, India
Distribution
- Quantity
- 9,336 Tubes
- Distribution pattern
- DE and NC
Timeline
- Recall initiated
- 2025-04-24
- FDA classified
- 2025-05-19
- Posted by FDA
- 2025-05-28
- Terminated
- 2026-02-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0429-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.