Reported Aug 8, 2018 · Terminated
Valsartan 320 mg tablets, 30-count bottles ( NDC 63629-6905-1), 90-count bottles (NDC 63629-6905-2), 28-count bottles…
Bryant Ranch Prepack Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bryant Ranch Prepack Inc. · 1919 N Victory Pl · Burbank, CA · 91504-3425
Is this the product you have?
Valsartan 320 mg tablets30-count bottles ( NDC 63629-6905-1)90-count bottles (NDC 63629-6905-2)28-count bottles (NDC 6362-96905-3)Rx OnlyPackaged by Bryant RanchBurbankCA 91504
- Lot codes and dates
Lot # 114319Exp. 10/18 Lot # 109004Exp. 12/18
- Amount recalled
- 990 tablets
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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