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Recall Observatory FDA recall evidence

Drug product

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

D-0750-2021

July 19, 2021

Class II

Product summary

Firm
Dr. Reddy's Laboratories, Inc.
Event
Event 88309
Status
Terminated
Classification
Class II
Quantity
37560 bottles
Official record key
drug-enforcement:D-0750-2021

Official wording

Reason: Failed Tablet/Capsule Specification: Some tablets are shaved

Code information: Lot #: T2000471, exp date 09/2023

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Failed Tablet/Capsule Specification: Some tablets are shaved