Drug Enforcement D-0429-2025

CGMP Deviations

Status

Ongoing

Classification

Class II

Report Date

May 28, 2025

Termination Date

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Product Information

Product description
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.
Product quantity
9,336 Tubes
Reason for recall
CGMP Deviations
Recall initiation reason
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Initial firm notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution pattern
DE and NC

Location & Firm

Recalling firm
KENIL HEALTHCARE PRIVATE LIMITED
Address
Plot 319, Village Acharasan, Ankhol-Vamaj Road

India
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0429-2025
Event ID
96797
Recall initiation date
April 24, 2025
Center classification date
May 19, 2025
Code info
Lot SP27A, Exp: 09/30/2026
More code info
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