FDAFDA · Food and drugs·Recall number D-0315-2019
Valsartan Tablets, USP, 40 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-5807-93.
Published December 19, 2018 · Recall initiated: November 20, 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
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Brand
- VALSARTAN
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Distributor
- Product was distributed throughout the United States.
- UPC
- 0303785815778
- Lot
- Lot # 3061169, exp. date 11/2018
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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