FDAFDA · Food and drugs·Recall number D-0322-2019
Amlodipine and Valsartan Tablets, USP 5/320 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-1723-93.
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
- AMLODIPINE AND VALSARTAN
- Manufacturer
- Mylan Laboratories Limited, (Nashik FDF)
- Distributor
- Product was distributed throughout the United States to several major distributors, including Puerto Rico.
- UPC
- 0303781722933
- Lot
- Lot Numbers: 3064086, 3066061, 3066062,3073145,3073146,3073147, 3076091, 3077619, 3082432
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- India
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