Aurobindo Recalls Valsartan Tablets Due to NDEA Impurity
Aurobindo Pharma USA Inc. is recalling Valsartan tablets because FDA testing found N-nitrosodimethylamine (NDEA) above the acceptable daily intake level.
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 impurities.
Plain-English summary
Aurobindo Pharma USA Inc. is recalling 20,604 bottles of Valsartan tablets USP 320 mg, 90-count bottles. The affected products are identified by Lot # VUSD17008-A (exp. 07/2019) and Lot # VUSD17009-A (exp. 09/2019), with NDC 65862-573-90.
The recall was initiated because FDA laboratory testing 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.
The product was distributed to 25 distributors and retail chains, which may have further distributed the product throughout the United States. Consumers should check their medication for the specific lot numbers and expiration dates listed above. If the medication matches the recalled lots, patients should contact their healthcare provider or pharmacist for guidance on alternative treatment options.
The recalled product
- Product
- VALSARTAN (VALSARTAN)
- Brand
- VALSARTAN
- Manufacturer
- Aurobindo Pharma USA Inc.
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 20,604
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 # VUSD17008-A
- exp. date 07/2019 Lot # VUSD17009-A
- exp. date 09/2019
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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