FDAClass IINovember 21, 2018

Isosorbide Dinitrate Tablets recall: Contamination

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

Why was Isosorbide Dinitrate Tablets recalled?

Cross Contamination with Other Products

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lots: a) JA9535 Exp. 05/2021.

Product
Isosorbide Dinitrate Tablets, USP 20 mg, 100-count bottles, Rx Only, Distributed by: Sandoz Inc. Princeton, NJ 08540; NDC 0781-1695-01
Recalling firm
Sandoz Inc
Quantity
18,832 bottles
Distribution
Nationwide within the United States
Recall date
November 21, 2018
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls