Reported Aug 1, 2018 · Terminated
Unit Dose Valsartan Tablets, USP. 160 mg. Rx only.,Distributed by: Major Pharmaceuticals, Livonia, MI 48152, NDC#…
Major Pharmaceuticals
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: MAJOR PHARMACEUTICALS · 17177 N Laurel Park Dr · Livonia, MI · 48152-2693
Is this the product you have?
- Unit Dose Valsartan Tablets, USP. 160 mg. Rx only
- Distributed byMajor Pharmaceuticals, Livonia, MI 48152, NDC# 0904-6594-61. NDC# 0904-6595-61
- Lot codes and dates
- Major Label Unit Dose 10 x 10 Cartons 160 mg Item # 302087. Lot#
- T-01269 (Expiry7/18). Lot#
- T-01524 (Expiry2/19). Lot#
- T-01646 (Expiry5/19). Lot#
- T-01668 (Expiry5/19). Lot#
- T-01788 (Expiry5/19)
- Amount recalled
- 4,556 cartons
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
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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