Drug Enforcement D-0659-2024

Discoloration

Status

Ongoing

Classification

Class III

Report Date

September 25, 2024

Termination Date

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Product Information

Product description
AcetaZOLAMIDE Tablets, USP, 125 mg, 100 count bottled, Rx Only, Distributed by: Advagen Pharma Limited, Plainsboro, NJ, Manufactured by Rubicon Research Private Limited, Thane, India NDC 72888-047-01
Product quantity
3,984 bottles
Reason for recall
Discoloration
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide in the US

Location & Firm

Recalling firm
Rubicon Research Private Limited
Address
4 & K30 5 Plot No K - 30

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

Recall number
D-0659-2024
Event ID
95217
Recall initiation date
August 24, 2024
Center classification date
September 13, 2024
Code info
Lot # 30575HF1, exp. date, Nov 2026 NDC# 72888-047-01
More code info
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