Rising Pharmaceuticals Recalls Valsartan Tablets Due to NDEA Impurity
Rising Pharmaceuticals is recalling Valsartan Tablets 320 mg due to CGMP deviations and the detection of a trace amount of the impurity N-nitrosodiethylamine (NDEA).
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a 'Severe' rating under the rubric, particularly given the presence of a nitrosamine impurity (NDEA) which is a known carcinogen.
Plain-English summary
Rising Pharmaceuticals, Inc. is recalling Valsartan Tablets 320 mg USP, 90 tablet bottles (NDC 52343-125-90). The product was distributed by Acetris Health, LLC and manufactured by Aurolife Pharma LLC. A total of 42,016 bottles are subject to this recall.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations and the detection of a trace amount of the unexpected impurity N-nitrosodiethylamine (NDEA) in the finished products. The affected lots include specific expiration dates ranging from October 2019 to July 2020.
The product was distributed to six major distributors, who may have further distributed the product throughout the United States. Consumers should check their medication for the specific NDC and lot numbers listed in the official recall notice and contact their healthcare provider or pharmacist for guidance on alternative treatments.
The recalled product
- Product
- 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
- Manufacturer
- Rising Pharmaceuticals, Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 42,016
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- 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
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 4 recalled by Rising Pharmaceuticals, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
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- SevereRising Pharmaceuticals Recalls Valsartan Tablets Due to NDEA Impurity
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