Mylan Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity
Mylan Pharmaceuticals is recalling Amlodipine and Valsartan tablets because FDA testing found the impurity N-nitrosodiethylamine (NDEA) in the active ingredient.
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 recall is classified as FDA Class II, which typically indicates a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The presence of NDEA, a potential carcinogen, in a prescription drug elevates the severity to Severe (4) per the rubric for significant injury/property-damage reports or high-risk contamination.
Plain-English summary
Mylan Pharmaceuticals Inc. is recalling Amlodipine and Valsartan Tablets, USP, 5 mg/160 mg, 30-count bottles. The recall involves 23,478 bottles of the prescription medication, which was distributed throughout the United States. The specific lot number is 3066051, with an expiration date of 3/2019.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. FDA laboratory testing confirmed the presence of N-nitrosodiethylamine (NDEA), a known impurity, in the active pharmaceutical ingredient (API) used to manufacture the product. NDEA is a potential carcinogen.
Consumers and healthcare providers should stop using the affected medication and contact their healthcare provider for alternative treatment options. The product should be returned to the pharmacy or disposed of according to local regulations.
The recalled product
- Product
- AMLODIPINE AND VALSARTAN (AMLODIPINE AND VALSARTAN)
- Brand
- AMLODIPINE AND VALSARTAN
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 23,478
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 (2)
- Lot # 3066051
- exp. date 3/2019
UPCs (4)
- 0303781722933
- 0303781723930
- 0303781721936
- 0303781724937
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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