Mylan Recalls Valsartan and Hydrochlorothiazide Tablets Due to NDEA Impurity
Mylan is recalling Valsartan and Hydrochlorothiazide tablets because FDA analysis found trace amounts of the impurity NDEA in the active ingredient.
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 potential carcinogen (NDEA) in a prescription drug.
Plain-English summary
Mylan Laboratories Limited is recalling specific lots of Valsartan and Hydrochlorothiazide Tablets, USP 320/25 mg. The recall involves 32,284 HDPE bottles in 90-count and 500-count sizes. The product is a prescription medication manufactured in India for Mylan Pharmaceuticals, Inc.
The recall was initiated because FDA analysis confirmed the presence of trace amounts of N-nitrosodiethylamine (NDEA), an impurity, in the active pharmaceutical ingredient (API) used to manufacture the product. NDEA is a potential carcinogen.
The affected product was distributed throughout the United States to several major distributors, including Puerto Rico. Patients taking this medication should contact their healthcare provider for guidance on alternative treatments. Do not stop taking the medication without consulting a doctor.
The recalled product
- Product
- VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE)
- Brand
- VALSARTAN AND HYDROCHLOROTHIAZIDE
- Manufacturer
- Mylan Laboratories Limited, (Nashik FDF)
- Category
- Drug — Prescription Medication
- Affected units
- 32,284
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 (1)
- Lot numbers: 3084860 3084861 3084862 3093804 3084862 3084863
UPCs (1)
- 0303786323777
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 13 recalled by Mylan Laboratories Limited, (Nashik FDF) 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 13 products in this recall →Related recalls
Same brand · VALSARTAN AND HYDROCHLOROTHIAZIDE
- SevereAurobindo Recalls Valsartan and Hydrochlorothiazide Tablets Due to NDEA Impurity
FDA (Drugs) · 2019-01-23
- SevereAurobindo Recalls Valsartan and Hydrochlorothiazide Tablets Due to NDEA Impurity
FDA (Drugs) · 2019-01-23
- SevereAurobindo Recalls Valsartan and Hydrochlorothiazide Tablets Due to NDEA Impurity
FDA (Drugs) · 2019-01-23
- SevereAurobindo Recalls Valsartan and Hydrochlorothiazide Tablets Due to NDEA Impurity
FDA (Drugs) · 2019-01-23
- SevereAurobindo Recalls Valsartan and Hydrochlorothiazide Tablets Due to NDEA Impurity
FDA (Drugs) · 2019-01-23
Same manufacturer · Mylan Laboratories Limited, (Nashik FDF)
See all →- SevereMylan Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity
FDA (Drugs) · 2018-12-19
- HighMylan Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity
FDA (Drugs) · 2018-12-19
- SevereMylan Recalls Valsartan and Hydrochlorothiazide Tablets Due to NDEA Impurity
FDA (Drugs) · 2018-12-19
- SevereMylan Recalls Valsartan Tablets Due to NDEA Impurity
FDA (Drugs) · 2018-12-19
- SevereMylan Recalls Valsartan Tablets Due to Trace NDEA Impurity
FDA (Drugs) · 2018-12-19
Same hazard · nde contamination
See all →- SevereRising Pharmaceuticals Recalls Valsartan Tablets Due to NDEA Impurity
FDA (Drugs) · 2019-03-27
- SevereAurobindo Pharma Recalls Valsartan Tablets Due to NDEA Impurity
FDA (Drugs) · 2019-03-27
- SeverePrinston Recalls Irbesartan 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 and Hydrochlorothiazide Tablets Due to NDEA Impurity
FDA (Drugs) · 2019-02-06