Valsartan/HCTZ 160 mg/12 recalled over manufacturing violations
- Recall date
- July 17, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- RemedyRepack Inc. recalls Valsartan/HCTZ 160 mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter Drive, Suite 4, Indiana, PA 15…
- Recall number
- D-1020-2018
- FDA classification
- Class II
- Brand / firm
- RemedyRepack Inc.
- Sold / distributed
- Product was distributed to 3 medical facilities in Florida.
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 mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter Drive, Suite 4, Indiana, PA 15701
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