Amlodipine and Valsartan Tablets USP 5 mg/160 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-737-30
Reported: January 23, 2019 Initiated: December 31, 2018 #D-0361-2019
Product Description
Amlodipine and Valsartan Tablets USP 5 mg/160 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-737-30
Reason for Recall
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Details
- Recalling Firm
- Aurobindo Pharma USA Inc.
- Units Affected
- 18,408 bottles
- Distribution
- Product was distributed to 25 distributors and Retail Chains who may have further distributed the product throughout the United States.
- Location
- East Windsor, NJ
Frequently Asked Questions
What product was recalled? ▼
Amlodipine and Valsartan Tablets USP 5 mg/160 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-737-30. Recalled by Aurobindo Pharma USA Inc.. Units affected: 18,408 bottles.
Why was this product recalled? ▼
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 23, 2019. Severity: Moderate. Recall number: D-0361-2019.
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