FDAFDA · Food and drugs·Recall number D-0328-2019
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 for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A.
Published December 19, 2018 · Recall initiated: December 4, 2018
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Brand
- VALSARTAN AND HYDROCHLOROTHIAZIDE
- Manufacturer
- Mylan Laboratories Limited, (Nashik FDF)
- Distributor
- Product was distributed throughout the United States to several major distributors, including Puerto Rico.
- UPC
- 0303786323777
- Lot
- Lot numbers: 3084363, 3084364, 3093800, 3084363, 3093800
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- India
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