Aurobindo Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity
Aurobindo Pharma USA Inc. is recalling Amlodipine and Valsartan tablets because FDA labs found N-nitrosodimethylamine (NDEA) above acceptable levels.
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 classification is FDA Class II, and the presence of NDEA, a potential carcinogen, above acceptable levels constitutes a significant health risk warranting a Severe rating.
Plain-English summary
Aurobindo Pharma USA Inc. is recalling Amlodipine and Valsartan Tablets USP 5 mg/320 mg, 30-count bottles. The recall involves 27,688 bottles with lot numbers VMSA17012-A through VMSA17017-A, all with an expiration date of 11/2019. The product was distributed to 25 distributors and retail chains who may have further distributed the product throughout the United States.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. FDA laboratories confirmed the presence of the impurity N-nitrosodimethylamine (NDEA) in the active pharmaceutical ingredient (API) used to manufacture the product. The levels of NDEA were found to be above the interim acceptable daily intake level of 0.083 parts per million.
Consumers who have this medication should stop using it and contact their healthcare provider for guidance on alternative treatments. The product is prescription-only, so patients should consult their prescriber before discontinuing or switching medications.
The recalled product
- Product
- AMLODIPINE AND VALSARTAN (AMLODIPINE AND VALSARTAN)
- Brand
- AMLODIPINE AND VALSARTAN
- Manufacturer
- Aurobindo Pharma USA Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 27,688
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 (7)
- Lot # VMSA17012-A
- exp. date 11/2019 Lot # VMSA17013-A
- exp. date 11/2019 Lot # VMSA17014-A
- exp. date 11/2019 Lot # VMSA17015-A
- exp. date 11/2019 Lot # VMSA17016-A
- exp. date 11/2019 Lot # VMSA17017-A
- exp. date 11/2019
UPCs (2)
- 0365862739308
- 0365862737304
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 10 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 10 products in this recall →Related recalls
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