August 24, 2018
Northwind Pharmaceuticals and Remedy Repack Inc. have joined a wave of firms issuing voluntary recalls for valsartan products in recent weeks. A carcinogenic substance, N-nitrosodimethylamine (NDMA), was found in valsartan medications manufactured by Zhejiang Huahai Pharmaceuticals in Linhai, China, Zhejiang Tianyu Pharmaceuticals in Taizhou, China, and Hetero Labs Limited, in India.
According to the August 22, 2018, FDA Enforcement Report, Northwind Pharmaceuticals is now recalling the following valsartan products, which were distributed in Indiana:
- valsartan, 80 mg, 30 tablets per bottle (NDC 51655-0652-52), from lot UT48310002 (Exp. 10/31/2018);
- valsartan, 160 mg, 30 tablets per bottle (NDC 51655-460-52), from lots UT48320002 (Exp. 7/31/18) and UT48320003 (Exp. 5/31/19);
- valsartan/hydrochlorothiazide, 160 mg/12.5 mg, 30 tablets per bottle (NDC 51655-950-52), from lot UTB23790003 (Exp. 2/28/19); and
- valsartan, 320 mg, 30 tablets per bottle (NDC 51655-0654-52), from lot UT48100001 (Exp. 9/30/19).
The recall was issued by Northwind Pharmaceuticals July 18, 2018.
On August 10, 2018, Remedy Repack initiated a recall for the following products, which were distributed to customers in Florida and Virginia:
- valsartan 80 mg, 90 tablets per bottle (NDC 61786-791-19), from lots B0335344-081717 (Exp. 8/18), B0363364-110917 (Exp. 11/18), B0391225-012218 (Exp. 1/19), B0408458-030618 (Exp. 3/19), B0384871-010318 (Exp. 1/19), and B0436862-051518 (Exp. 5/19);
- valsartan, 160 mg, 90 tablets per bottle (NDC 61786-792-19), from lots B0335344-081717 (Exp. 8/18), B0363364-110917 (Exp. 11/18), B0391225-012218 (Exp. 1/19), B0408458-030618 (Exp. 3/19), B0384871-010318 (Exp. 1/19), and B0436862-051518 (Exp. 5/19); and
- valsartan, 320 mg, 90 tablets per bottle (NDC 61786-793-19), from lots B0362988-110917 (Exp. 10/18), B0432265-050318 (Exp.5/19), B0450321-061218 (Exp. 6/19), B0450322-061218 (Exp. 5/19), and B0408652-030718 (Exp. 2/19).
In mid-August, the FDA designated both recalls Class II. Drugs included in Class II recalls may cause temporary or medically reversible adverse health consequences if used. Although remote, a possibility of serious harm also exists.
As of August 22, 2018, a Reuters analysis put the number of companies that have issued valsartan recalls in recent weeks at more than 50 worldwide.
Valsartan is a prescription angiotensin receptor blocker used to treat patients with high blood pressure and congestive heart failure.
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