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Recall Observatory FDA recall evidence

Drug product

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

D-0659-2024

August 24, 2024

Class III

Product summary

Firm
Rubicon Research Private Limited
Event
Event 95217
Status
Ongoing
Classification
Class III
Quantity
3,984 bottles
Official record key
drug-enforcement:D-0659-2024

Official wording

Reason: Discoloration

Code information: Lot # 30575HF1, exp. date, Nov 2026 NDC# 72888-047-01

Distribution pattern: Nationwide in the US

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Discoloration