Mylan Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity
Mylan Pharmaceuticals is recalling Amlodipine and Valsartan tablets because FDA testing 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 recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric, particularly given the presence of a known carcinogenic impurity (NDEA) in a prescription drug.
Plain-English summary
Mylan Pharmaceuticals Inc. is recalling Amlodipine and Valsartan Tablets, USP, 10 mg/160 mg, 30-count bottles. The recall involves 12,336 bottles of the prescription medication, which was distributed throughout the United States. The specific lot affected is #3079500 with an expiration date of 1/2020.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. FDA laboratory testing confirmed the presence of N-nitrosodiethylamine (NDEA), an impurity contained in the active pharmaceutical ingredient (API) used to manufacture the product.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider for guidance on alternative treatments. The product is identified by NDC 0378-1722-93.
The recalled product
- Product
- AMLODIPINE AND VALSARTAN (AMLODIPINE AND VALSARTAN)
- Brand
- AMLODIPINE AND VALSARTAN
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 12,336
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 # 3079500
- 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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