US Drug Recall Register
Class II · Moderate risk Terminated Initiated Nov 2, 2018 (8 years ago)

Isosorbide Dinitrate Tablets

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Cross Contamination with Other Products

What was recalled

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
NDC code
0781-1695-01
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0258-2019

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

Other Isosorbide recalls

See all
Class II · Moderate risk Terminated

Isosorbide Dinitrate Tablets

Reason Cross Contamination with Other Products

Sandoz Inc NDC 68001-222-00 D-0261-2019
Class II · Moderate risk Terminated

Isosorbide Dinitrate Tablets

Reason Cross Contamination with Other Products

Sandoz Inc NDC 68001-225-00 D-0260-2019
Class II · Moderate risk Terminated

Isosorbide Dinitrate Tablets

Reason Cross Contamination with Other Products

Sandoz Inc NDC 68001-223-00 D-0259-2019
Class II · Moderate risk Terminated

Isosorbide Dinitrate active pharmaceutical ingredient packaged in…

Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

Attix Pharmaceuticals D-737-2015
Class II · Moderate risk Terminated

ISOSORBIDE MONONITRATE ER Tablet

Reason Labeling:Label Mixup; ISOSORBIDE MONONITRATE ER Tablet, 30 mg may be potentially mislabeled as LOSARTAN POTASSIUM, Tablet, 25 mg, NDC 16714058102, Pedigree: W003899, EXP: 6/27/2014; MISOPROSTOL, Tablet, 100 mcg, NDC 43386016012, Pedigree: AD42611_7, EXP: 5/14/2014; hydrOXYzine PAMOATE, Capsule, 100 mg, NDC 00555032402, Pedigree: W003332, EXP: 6/18/2014; glyBURIDE, Tablet, 2.5 mg, NDC 0009383

Aidapak Services, LLC D-671-2014