Mylan Recalls Valsartan and Hydrochlorothiazide Tablets Due to NDEA Impurity
Mylan Pharmaceuticals is recalling specific lots of Valsartan and Hydrochlorothiazide tablets because FDA labs confirmed the presence of the impurity N-nitrosodiethylamine (NDEA).
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant health risks like NDEA impurities are categorized as Severe (Score 4), as they are not Class I (Critical) but involve more than minor labeling issues.
Plain-English summary
Mylan Pharmaceuticals Inc. is recalling 5,660 bottles of Valsartan and Hydrochlorothiazide Tablets, USP, 320 mg/25 mg. The affected product is a 500-count bottle, prescription-only, manufactured in India for Mylan Pharmaceuticals, Inc., Morgantown, WV. The specific lots involved are Lot # 3084886 (exp. date 2/2019) and Lot # 3093804 (exp. date 12/2019), with NDC 0378-6325-05.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. FDA laboratory testing confirmed the presence of an impurity, N-nitrosodiethylamine (NDEA), in the active pharmaceutical ingredient (API) used to manufacture the product.
The product was distributed throughout the United States. Consumers and healthcare providers should check their medication for the specific lot numbers and expiration dates listed above. If the medication matches the recalled lots, patients should stop taking it and consult their healthcare provider for alternative treatment options.
The recalled product
- Product
- VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE)
- Brand
- VALSARTAN AND HYDROCHLOROTHIAZIDE
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 5,660
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 (3)
- Lot # 3084886
- exp. date 2/2019 Lot # 3093804
- exp. date 12/2019
UPCs (1)
- 0303786323777
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 8 recalled by Mylan 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 8 products in this recall →Related recalls
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