Aurobindo Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity
Aurobindo Pharma USA Inc. is recalling Amlodipine and Valsartan tablets because FDA analysis found trace amounts 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 for drug recalls involving potential carcinogenic impurities.
Plain-English summary
Aurobindo Pharma USA Inc. is recalling Amlodipine and Valsartan Tablets USP 10mg/160mg, 30 count bottles. The product is identified by NDC 65862-739-30 and Lot Number VFSA17007-A with an expiration date of Oct-2019. The tablets were manufactured by Aurobindo Pharma Limited in India for Aurobindo Pharma USA, Inc. in Dayton, NJ.
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. NDEA is a nitrosamine impurity that is a potential carcinogen.
The product was distributed to major distribution chains throughout the United States. Consumers and healthcare providers should check their inventory for the specific lot number and expiration date listed above. If the product is found, it should be returned to the pharmacy or distributor for a refund or replacement.
The recalled product
- Product
- AMLODIPINE AND VALSARTAN (AMLODIPINE AND VALSARTAN)
- Brand
- AMLODIPINE AND VALSARTAN
- Manufacturer
- Aurobindo Pharma USA Inc.
- Category
- Drug — Prescription Drug
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 Numbers: VFSA17007-A
- exp. date Oct-2019
UPCs (2)
- 0365862739308
- 0365862737304
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 5 recalled by Aurobindo Pharma USA 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 5 products in this recall →Related recalls
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