Hypertension Tablets Recalled

Two companies have initiated valsartan recalls because a carcinogen impurity was detected in an active pharmaceutical ingredient (API) used to manufacture the drug. The new recalls were included in the August 8, 2018, US Food and Drug Administration (FDA) Enforcement Report.

Bryant Ranch Prepack Inc. is recalling the following valsartan products, which were distributed in Hawaii, Indiana, and Florida:

• valsartan 80-mg tablets, 90-count bottles (NDC 63629-6922-2), 60-count bottles (NDC 63629-6922-3), and 28-count bottles (NDC 63629-6922-4), from lot 111158 (Exp. 2/19);
• valsartan 320-mg tablets, 30-count bottles (NDC 63629-6905-1), 90-count bottles (NDC 63629-6905-2), and 28-count bottles (NDC 6362-96905-3), from lots 114319 (Exp. 10/18) and 109004 (Exp. 12/18); and
• valsartan 320-mg tablets, 90-count bottles (NDC 71335-0567-2), from lot 120879 (Exp. 10/19).

In addition, H.J. Harkins Company Inc, which also goes by Pharma Pac, is recalling valsartan 160-mg tablets, 90-count bottles (NDC 43547-0369-09), from lot VSA000OV. The tablets were repackaged by H.J. Harkins Company from the original lot 343B17015 (Exp. 2/19) and were distributed to a physician’s office.

The recalls were voluntarily initiated by H.J. Harkins Company on July 26, 2018, and by Bryant Ranch Prepack on July 27, 2018. The FDA designated the recalls Class II during the first week of August 2018. The classification signals use of the affected drug may cause temporary or medically reversible adverse health consequences, as well as a remote possibility of serious harm.

Valsartan is a prescription angiotensin receptor blocker used to treat patients with high blood pressure and congestive heart failure.

—Jolynn Tumolo

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