FDAFDA · Food and drugs·Recall number D-1055-2019
Valsartan Tablets 320 mg USP, 90 tablet bottles, Distributed by: Acetris Health, LLC, Saddle Brook, NJ 07663, Manufactured by: Aurolife Pharma LLC, Dayton, NJ 08810 --- NDC 52343-125-90
Published March 27, 2019 · Recall initiated: March 7, 2019
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; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Rising Pharmaceuticals, Inc.
- Distributor
- Product was distributed to 6 major distributors who may have further distributed the product throughout the United States.
- Lot
- 473180007A, exp. date 03/31/2020 473180008A, exp. date 03/31/2020 473180011A, exp. date 04/30/2020 473180020B1, exp. date 07/31/2020 473170019B, exp. date 10/31/2019
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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