Recall Expands Over Carcinogen Presence

NuCare Pharmaceuticals Inc. is joining a number of other firms that have issued voluntary recalls for valsartan products in recent weeks after a carcinogen impurity was detected in an active pharmaceutical ingredient (API) used to manufacture the drug.

WebMD reports the carcinogenic substance is N-nitrosodimethylamine (NDMA), which was found in drugs manufactured by Zhejiang Huahai Pharmaceuticals in Linhai, China, Zhejiang Tianyu Pharmaceuticals in Taizhou, China, and Hetero Labs Limited, in India. The US Food and Drug Administration (FDA) is reportedly working with other makers of valsartan ingredients to investigate whether processes used in manufacturing may be causing the formation of NDMA.

According to the August 15, 2018, FDA Enforcement Report, NuCare Pharmaceuticals is recalling

• 90-count bottles of valsartan/hydrochlorothiazide 160/12.5 mg tablets (NDC 68071-4311-9) from lot U01779 (Exp. 4/30/19),
• 30-count bottles of valsartan/hydrochlorothiazide 160/25 mg tablets from lot T11443 (Exp. 2/28/19), and
• 30-count bottles of valsartan/hydrochlorothiazide 320/25 mg tablets (NDC 68071-4183-3) from lot T11577 (Exp. 6/30/19).

The recalled drugs were distributed in Florida and California.

NuCare Pharmaceuticals initiated its recall July 30, 2018. On August 3, 2018, the FDA designated the recall Class II. Drugs included in Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.

Valsartan is a prescription angiotensin receptor blocker used to treat patients with high blood pressure and congestive heart failure. So far this August, the FDA has also announced valsartan product recalls issued by Prinston Pharmaceutical Inc., Teva Pharmaceuticals USA, Bryant Ranch Prepack Inc., and H.J. Harkins Company Inc./Pharma Pac. A full list of valsartan recalls is available on the FDA website.

—Jolynn Tumolo

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