Class II
Ongoing
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
This recall is currently active, issued March 27, 2019. It was issued by Rising Pharmaceuticals, Inc..
- Company
- Rising Pharmaceuticals, Inc.
- Recall Initiated
- March 7, 2019
- Posted
- March 27, 2019
- Recall Number
- D-1052-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 30,530 bottles
- Firm Location
- Saddle Brook, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products
Distribution
Product was distributed to 6 major distributors who may have further distributed the product throughout the United States.
Lot / Code Info
470170038A, exp. date 10/31/2019 470180010A, exp. date 02/29/2019 470180012A, exp. date 03/31/2020
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