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Heart Drug Recalled


November 21, 2018

Concerned about cross-contamination with other products, Sandoz Inc. is recalling several strengths of isosorbide dinitrate tablets, USP, according to the November 21, 2018, US Food and Drug Administration (FDA) Enforcement Report.

The voluntary recall includes the following tablets, packaged in 100-count bottles, which were distributed within the United States:

  • 5-mg isosorbide dinitrate tablets manufactured by Sandoz for BluePoint Laboratories (NDC 68001-223-00) from lot HZ7896 (Exp. 5/21);
  • 10-mg isosorbide dinitrate tablets manufactured by Sandoz for BluePoint Laboratories (NDC 68001-223-00) from lot JA3077 (Exp. 5/21);
  • 20-mg isosorbide dinitrate tablets manufactured by Sandoz for BluePoint Laboratories (NDC 68001-223-00) from lot JA9534 (Exp. 5/21); and
  • 20-mg isosorbide dinitrate tablets distributed by Sandoz (NDC 0781-1695-01) from lot JA9535 (Exp. 5/21).

Sandoz initiated the recall November 2, 2018. On November 20, 2018, the FDA designated it Class II. The categorization suggests use of recalled tablets could cause temporary or medically reversible harm, or a remote probability of serious adverse health consequences.

Isosorbide dinitrate is a prescription nitrate used to prevent chest pain in patients with coronary artery disease.

Jolynn Tumolo


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