Amlodipine and Valsartan Tablets USP 10mg/160mg, 30 count bottles, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ Manufactured by: Aurobindo Pharma Limited, India --- NDC 65862-739-30
Reported: March 27, 2019 Initiated: December 31, 2018 #D-1036-2019
Product Description
Amlodipine and Valsartan Tablets USP 10mg/160mg, 30 count bottles, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ Manufactured by: Aurobindo Pharma Limited, India --- NDC 65862-739-30
Reason for Recall
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Details
- Recalling Firm
- Aurobindo Pharma USA Inc.
- Units Affected
- N/A
- Distribution
- Product was distributed to major distribution chains throughout the United States.
- Location
- East Windsor, NJ
Frequently Asked Questions
What product was recalled? ▼
Amlodipine and Valsartan Tablets USP 10mg/160mg, 30 count bottles, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ Manufactured by: Aurobindo Pharma Limited, India --- NDC 65862-739-30. Recalled by Aurobindo Pharma USA Inc.. Units affected: N/A.
Why was this product recalled? ▼
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 27, 2019. Severity: Moderate. Recall number: D-1036-2019.
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