FDAFDA · Food and drugs·Recall number D-0364-2019
Amlodipine and Valsartan Tablets USP 10 mg/320 mg. 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-740-30.
Published January 23, 2019 · Recall initiated: December 31, 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-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Brand
- AMLODIPINE AND VALSARTAN
- Manufacturer
- Aurobindo Pharma USA Inc.
- Distributor
- Product was distributed to 25 distributors and Retail Chains who may have further distributed the product throughout the United States.
- UPC
- 0365862739308
- Lot
- Lot # VKSA18005-A, exp. date 03/2020 Lot # VKSA18001-A, exp. date 01/2020
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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