FDAFDA · Food and drugs·Recall number D-1052-2019
Valsartan Tablets 40 mg USP, 30 tablet bottles, Rx, Only, Distributed by: Acetris Health, LLC, Saddle Brook, NJ, Manufactured by: Aurolife Pharma LLC, Dayton, NJ ---- NDC 52343-122-30
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
- 470170038A, exp. date 10/31/2019 470180010A, exp. date 02/29/2019 470180012A, exp. date 03/31/2020
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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