Reported Dec 19, 2018 · Ongoing
Valsartan and Hydrochlorothiazide Tablets, USP 80/12.5 mg, (a) 90-count bottle (NDC 0378-6321-77), (b) 500-count…
Mylan Laboratories Limited, (Nashik FDF)
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: Mylan Laboratories Limited, (Nashik FDF) · F-4 F-12, Malegaon M.I.D.C., Sinnar · Sinnar, Nashik District, N/A · N/A
Is this the product you have?
- Valsartan and Hydrochlorothiazide Tablets, USP 80/12.5 mg, (a) 90-count bottle (NDC 0378-6321-77), (b) 500-count bottles (NDC 0378-6321-05), Rx Only, Made in India
- Manufactured forMylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A
- Lot codes and dates
- Lot numbers
30843633084364309380030843633093800
- Lot numbers
- Amount recalled
- 32,696 HDPE bottles
This recall covers 13 products
The agency filed one notice per product. You are reading one of them; the other 12 are below.
Where it was sold
Why it was recalled
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the 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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