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, and the presence of NDEA, a potential carcinogen, in a prescription drug constitutes a significant health risk warranting a Severe rating.
Plain-English summary
Mylan Pharmaceuticals Inc. is recalling Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30-count bottles. The recall involves 48,302 bottles distributed throughout the United States. The affected lots are #3061986, #3079709, #3077618, and #3079708.
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.
Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product matches the recalled lots, it should be returned to the pharmacy or point of purchase for a refund or replacement.
The recalled product
- Product
- AMLODIPINE AND VALSARTAN (AMLODIPINE AND VALSARTAN)
- Brand
- AMLODIPINE AND VALSARTAN
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Category
- Drug — Prescription Drug
- Affected units
- 48,302
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 (5)
- Lot # 3061986
- exp. date 11/2018 Lot # 3079709
- exp. date 1/2020 Lot # 3077618
- exp. date 11/2019 Lot # 3079708
- exp. date 1/2020
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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