Aurobindo Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity
Aurobindo Pharma USA Inc. is recalling Amlodipine and Valsartan tablets because FDA testing found the impurity NDEA above acceptable daily intake levels.
What this means for you
Illness, injury, or structural failure has been reported. 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 rating under the rubric, particularly given the presence of a known carcinogenic impurity (NDEA) above acceptable limits.
Plain-English summary
Aurobindo Pharma USA Inc. is recalling Amlodipine and Valsartan Tablets USP 10 mg/320 mg, 30-count bottles. The recall involves 55,788 bottles from two specific lots: Lot # VKSA18005-A (exp. 03/2020) and Lot # VKSA18001-A (exp. 01/2020). The product was distributed to 25 distributors and retail chains, which may have further distributed the medication throughout the United States.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. FDA laboratory testing confirmed the presence of the impurity N-nitrosodimethylamine (NDEA) in the active pharmaceutical ingredient (API) used to manufacture the product. The detected levels of NDEA exceeded 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 or pharmacist for guidance on alternative treatment options. The recalled product is identified by NDC 65862-740-30 and the specific lot numbers and expiration dates listed above.
The recalled product
- Product
- AMLODIPINE AND VALSARTAN (AMLODIPINE AND VALSARTAN)
- Brand
- AMLODIPINE AND VALSARTAN
- Manufacturer
- Aurobindo Pharma USA Inc.
- Category
- Drug — Prescription Drug
- Affected units
- 55,788
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 (3)
- Lot # VKSA18005-A
- exp. date 03/2020 Lot # VKSA18001-A
- exp. date 01/2020
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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