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Recall Observatory FDA recall evidence

Drug product

Tizanidine Tablets, USP 4mg, 150-count bottle, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-180-15

D-0223-2024

January 02, 2024

Class II

Product summary

Firm
Dr. Reddy's Laboratories, Inc.
Event
Event 93713
Status
Completed
Classification
Class II
Quantity
38,952 bottles
Official record key
drug-enforcement:D-0223-2024

Official wording

Reason: Presence of Foreign tablets/capsules - identified as tizanidine 2 mg tablets.

Code information: Lot #: T2304007, Exp 7/31/2026

Distribution pattern: USA Nationwide

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Foreign tablets