FDAFDA · Food and drugs·Recall number D-1036-2019
Amlodipine and Valsartan Tablets USP 10mg/160mg, 30 count bottles, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ Manufactured by: Aurobindo Pharma Limited, India --- NDC 65862-739-30
Published March 27, 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
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 · Letter
Recall details
- Brand
- AMLODIPINE AND VALSARTAN
- Manufacturer
- Aurobindo Pharma USA Inc.
- Distributor
- Product was distributed to major distribution chains throughout the United States.
- UPC
- 0365862739308
- Lot
- Lot Numbers: VFSA17007-A, exp. date Oct-2019
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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