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 N-nitrosodiethylamine (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 agency classification is FDA Class II, and the presence of NDEA, a known carcinogenic impurity, in a prescription drug constitutes a significant health risk warranting a Severe rating under the rubric.
Plain-English summary
Mylan Laboratories Limited is recalling Valsartan and Hydrochlorothiazide Tablets, USP 160/12.5 mg, in 90-count and 500-count bottles. The recall involves 50,595 HDPE bottles distributed throughout the United States, including Puerto Rico, to several major distributors.
The recall was initiated because FDA analysis confirmed the presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA), in the active pharmaceutical ingredient (API) used to manufacture the product. The affected lot numbers are 2008880, 3084358, 3084359, 3093801, and 3084361.
Consumers should check their medication bottles for the affected lot numbers and NDC codes 0378-6322-77 or 0378-6322-05. If the medication matches the recalled product, patients should contact their healthcare provider or pharmacist for guidance on alternative treatment options.
The recalled product
- Product
- VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE)
- Brand
- VALSARTAN AND HYDROCHLOROTHIAZIDE
- Manufacturer
- Mylan Laboratories Limited, (Nashik FDF)
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 50,595
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
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