Valsartan/HCTZ 160/12 recalled over manufacturing violations
- Recall date
- July 30, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- NuCare Pharmaceuticals Inc recalls Valsartan/HCTZ 160/12.5 mg Tablets, 90-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange, CA 92867,…
- Recall number
- D-1037-2018
- FDA classification
- Class II
- Brand / firm
- NuCare Pharmaceuticals Inc
- Sold / distributed
- Distributed to three customers in Fl and CA
Why it was recalled
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Valsartan/HCTZ 160/12.5 mg Tablets, 90-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange, CA 92867, NDC 68071-4311-9
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