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Isosorbide Dinitrate Tablets, USP 20 mg, 100-count bottles, Rx Only, Distributed by: Sandoz Inc. ...

FDA Recall #D-0258-2019 — Class II — November 2, 2018

Recall #D-0258-2019 Date: November 2, 2018 Classification: Class II Status: Terminated

Product Description

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

Reason for Recall

Cross Contamination with Other Products

Recalling Firm

Sandoz Inc — Princeton, NJ

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

18,832 bottles

Distribution

Nationwide within the United States

Code Information

Lots: a) JA9535 Exp. 05/2021.

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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