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Recall Observatory FDA recall evidence

Drug product

Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100 Tablets bottle, Rx only, Manufactured by: Dr. Reddy's Laboratories Limited Bachupally-500 090 India\ NDC 55111-468-01

D-0727-2018

April 23, 2018

Class II

Product summary

Firm
Dr. Reddy's Laboratories, Inc.
Event
Event 79980
Status
Terminated
Classification
Class II
Quantity
8160 bottles
Official record key
drug-enforcement:D-0727-2018

Official wording

Reason: Presence of Foreign Tablets/Capsules: One foreign tablet identified as Clopidogrel 75 mg was found in a 100 count bottle of Metoprolol Succiante Extended-Release Tablets.

Code information: Batch # C706254, 08/2019

Distribution pattern: Nationwide

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Foreign Tablets