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Recall Observatory FDA recall evidence

Drug product

NDC 64380-721-06 TACROLIMUS CAPSULES, USP 1mg 100 Capsules Rx Only Manufactured by: Strides Pharma Science Ltd. Bengaluru - 562106, India Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816

D-0180-2021

December 22, 2020

Class III

Product summary

Firm
Strides Pharma Inc.
Event
Event 87027
Status
Terminated
Classification
Class III
Quantity
960 bottles
Official record key
drug-enforcement:D-0180-2021

Official wording

Reason: Failed Moisture Limits

Code information: Lot 7242728A; June 2023

Distribution pattern: PA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Failed Moisture Limits