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Recall Observatory FDA recall evidence

Drug product

Metoprolol Tartrate Tablets USP, 25mg, 1000 count bottle, Rx only, distributed by: TruPharma, LLC, Tampa, FL 33609, Manufactured by: Rubicon Research Private Limited, Ambernath Dist Thane 421506 India, NDC 52817-360-00

D-0517-2024

May 06, 2024

Class II

Product summary

Firm
Rubicon Research Private Limited
Event
Event 94542
Status
Ongoing
Classification
Class II
Quantity
11,664 Bottles
Official record key
drug-enforcement:D-0517-2024

Official wording

Reason: Presence of Foreign Substance: metal in tablet

Code information: Lot 231037H1, exp 6/2027

Distribution pattern: Nationwide

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Foreign Substance