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Combo Drug for High Blood Pressure Recalled
AvKARE Inc. is recalling more than 88,000 bottles of valsartan and hydrochlorothiazide tablets due to the detection of a carcinogen impurity in an active pharmaceutical ingredient (API) used to manufacture the drug.
The latest valsartan-related recall joins numerous others in recent weeks after the carcinogenic substance N-nitrosodimethylamine (NDMA) was found in drugs manufactured by Zhejiang Huahai Pharmaceuticals in Linhai, China, Zhejiang Tianyu Pharmaceuticals in Taizhou, China, and Hetero Labs Limited in India.
According to the September 12, 2018, US Food and Drug Administration (FDA) Enforcement Report, AvKARE is voluntarily recalling the following valsartan and hydrochlorothiazide products, which were distributed across the United States:
- 90-count bottles of valsartan and hydrochlorothiazide tablets, 80 mg/12.5 mg (NDC 42291-884-90), from lots 17349 (Exp. 8/18), 18395 (Exp. 8/18), 19221 (Exp. 6/19), 20029 (Exp. 6/19), 20158 (Exp. 7/19), 20843 (Exp. 7/19), and 21411 Exp. (9/19);
- 90-count bottles of valsartan and hydrochlorothiazide tablets, 160 mg/12.5 mg (NDC 42291-885-90), from lots 17325 (Exp. 9/18), 17856 (Exp. 9/18), 18396 (Exp. 9/18), 18702 (Exp. 2/19), 19020 (Exp. 2/19), 19222 (Exp. 2/19), 20030 (Exp. 4/19), and 20381 (Exp. 4/19);
- 90-count bottles of valsartan and hydrochlorothiazide tablets, 160 mg/25 mg (NDC 42291-887-90), from lots 17325 (Exp. 9/18), 17856 (Exp. 9/18), 18396 (Exp. 9/18), 18702 (Exp. 2/19), 19020 (Exp. 2/19), 19222 (Exp. 2/19), 20030 (Exp. 4/19), and 20381 (Exp. 4/19);
- 90-count bottles of valsartan and hydrochlorothiazide tablets, 320 mg/12.5 mg (NDC 42291-886-90), from lots 17780 (Exp. 9/18), 18029 (Exp. 9/18), 18398 (Exp. 9/18), 18723 (Exp. 9/18), 19017 (Exp. 2/19), 19224 (Exp. 2/19), 20032 (Exp. 8/19), 20289 (Exp. 8/19), 21076 (Exp. 8/19), and 21382 (Exp. 8/19); and
- 90-count bottles of valsartan and hydrochlorothiazide tablets, 320 mg/25 mg (NDC 42291-888-90), from lots 17308 (Exp. 9/18), 18158 (Exp. 9/18), 18539 (Exp. 1/19), 19021 (Exp. 1/19), 19225 (Exp. 1/19), 20033 (Exp. 6/19), 20290 (Exp. 6/19), 20565 (Exp. 06/19), and 21369 (Exp. 10/19).
AvKARE voluntarily initiated the recall July 18, 2018. On September 6, 2018, the FDA designated it Class II. The classification, which was issued for all the recent valsartan recalls, warns use of the affected drugs may cause temporary or medically reversible adverse health consequences. While remote, a possibility of serious harm also exists.
Valsartan and hydrochlorothiazide is a prescription combination medicine used to treat patients with high blood pressure.
—Jolynn Tumolo
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