Drug Enforcement D-0447-2025

Failed Impurities/Degradation Specifications

Status

Ongoing

Classification

Class II

Report Date

June 4, 2025

Termination Date

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Product Information

Product description
Bromfenac Ophthalmic Solution 0.09%, 1.7 mL bottle, Rx only, Sterile, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, Manufactured by Alembic Pharmaceuticals Limitied, Gujarat, India, Made in India, NDC 62332-508-17
Product quantity
N/A
Reason for recall
Failed Impurities/Degradation Specifications
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
US Nationwide

Location & Firm

Recalling firm
Alembic Pharmaceuticals Limited
Address
Formulation Division, Village Panelav, P.O. Tajpura, Near Baska, Taluka Halol, N/A

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

Recall number
D-0447-2025
Event ID
96836
Recall initiation date
May 7, 2025
Center classification date
May 27, 2025
Code info
Lot 7230309, Exp Date: 5/31/2025; Lot 7230310, Exp Date: 5/31/2025; Lot 7230311, Exp Date: 5/31/2025
More code info
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