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Recall Observatory FDA recall evidence

Drug product

Isosorbide Dinitrate Tablets, USP 20 mg, 100-count bottles, Rx Only, Distributed by: Sandoz Inc. Princeton, NJ 08540; NDC 0781-1695-01

D-0258-2019

November 02, 2018

Class II

Product summary

Firm
Sandoz Inc
Event
Event 81457
Status
Terminated
Classification
Class II
Quantity
18,832 bottles
Official record key
drug-enforcement:D-0258-2019

Official wording

Reason: Cross Contamination with Other Products

Code information: Lots: a) JA9535 Exp. 05/2021.

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Cross Contamination with Other Products