Rising Pharmaceuticals Recalls Valsartan Tablets Due to NDEA Impurity
Rising Pharmaceuticals is recalling Valsartan Tablets 160 mg due to CGMP deviations and the detection of a trace amount of the impurity 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 and involves the detection of NDEA, a known carcinogenic impurity, which aligns with the rubric criteria for Severe severity involving significant health risks.
Plain-English summary
Rising Pharmaceuticals, Inc. is recalling Valsartan Tablets 160 mg USP, 90 tablet bottles. The product is distributed by Acetris Health, LLC and manufactured by Aurolife Pharma LLC. The recall involves 35,281 bottles with specific lot codes and expiration dates listed in the agency notice.
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 agency has classified this recall as Class II.
The product was distributed to six major distributors who may have further distributed the product throughout the United States. Consumers and healthcare providers should check their inventory for the specific NDC 52343-124-90 and the listed lot codes to determine if they are affected.
The recalled product
- Product
- Valsartan Tablets 160 mg USP, 90 tablet bottles, Rx only, Distributed by: Acetris Health, LLC, Saddle Brook, NJ 07663, Manufactured by: Aurolife Pharma LLC, Dayton, NJ 08810 ---- NDC 52343-124-90
- Manufacturer
- Rising Pharmaceuticals, Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 35,281
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 (4)
- 472180005B
- exp. date 02/29/2020 472180011A
- exp. date 04/30/2020 472180012A
- exp. date 04/30/2020
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
Same manufacturer · Rising Pharmaceuticals, Inc.
See all →- LowRising Pharmaceuticals Recalls Timolol Maleate Ophthalmic Solution Due to Labeling Error
FDA (Drugs) · 2020-07-01
- LowRising Pharmaceuticals Recalls Timolol Maleate Ophthalmic Solution Due to Labeling Error
FDA (Drugs) · 2020-07-01
- SevereRising Pharmaceuticals Recalls Valsartan Tablets Due to NDEA Impurity
FDA (Drugs) · 2019-03-27
- SevereRising Pharmaceuticals Recalls Valsartan Tablets Due to NDEA Impurity
FDA (Drugs) · 2019-03-27
- SevereRising Pharmaceuticals Recalls Valsartan Tablets Due to NDEA Impurity
FDA (Drugs) · 2019-03-27
Same hazard · nde contamination
See all →- SevereAurobindo Pharma Recalls Valsartan Tablets Due to NDEA Impurity
FDA (Drugs) · 2019-03-27
- SeverePrinston Recalls Irbesartan and Hydrochlorothiazide Tablets Due to NDEA Impurity
FDA (Drugs) · 2019-02-06
- SeverePrinston Recalls Irbesartan and Hydrochlorothiazide Tablets Due to NDEA Impurity
FDA (Drugs) · 2019-02-06
- SeverePrinston Recalls Irbesartan Tablets Due to NDEA Impurity
FDA (Drugs) · 2019-02-06
- SevereAurobindo Recalls Valsartan and Hydrochlorothiazide Tablets Due to NDEA Impurity
FDA (Drugs) · 2019-01-23