Aurobindo Pharma Recalls Valsartan Tablets Due to NDEA Impurity
Aurobindo Pharma USA Inc. is recalling specific lots of Valsartan 40 mg tablets because FDA analysis found trace amounts of the impurity N-nitrosodiethylamine (NDEA).
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 severity score (4) under the rubric, particularly given the presence of a nitrosamine impurity (NDEA) which is a known carcinogen.
Plain-English summary
Aurobindo Pharma USA Inc. is recalling Valsartan Tablets USP 40 mg, 30 count bottles (NDC 65862-570-30). The recall is due to Good Manufacturing Practice (GCMP) deviations identified by the FDA, which confirmed the presence of trace amounts of the impurity N-nitrosodiethylamine (NDEA) in the active pharmaceutical ingredient (API) used to manufacture the product.
The affected product was distributed to major distribution chains throughout the United States. The specific lot numbers subject to the recall are 470180008A (exp. Feb 2020), 470180014A and 470180016A (exp. Mar 2020), and 470180032A (exp. May 2020).
Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product matches the recalled lots, it should be returned to the pharmacy or distributor for replacement or refund. Patients should consult their healthcare provider for alternative treatment options if necessary.
The recalled product
- Product
- VALSARTAN (VALSARTAN)
- Brand
- VALSARTAN
- Manufacturer
- Aurobindo Pharma USA Inc.
- Category
- Drug — Prescription Drug
- Hazard
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 Numbers: 470180008A
- exp. date Feb 2020
- 470180014A
- 470180016A
- exp. date Mar 2020
- 470180032A
- exp. date May 2020
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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- SevereAurobindo Pharma Recalls Valsartan Tablets Due to NDEA Impurity
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- SevereAurobindo Recalls Valsartan Tablets Due to NDEA Impurity
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- SevereAurobindo Recalls Valsartan Tablets Due to NDEA Impurity
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