Drug recall D-0361-2019
Product
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.
Lots and codes
Lot # VESA17013-A, exp. 10/2019 Lot # VESA17014-A, exp. 10/2019 Lot # VESA18001-A, exp. 12/2019 Lot # VESA18002-A, exp. 12/2019
Recall details
- Recalling firm
- Aurobindo Pharma USA Inc., East Windsor, NJ
- Quantity
- 18,408 bottles
- Distribution
- Product was distributed to 25 distributors and Retail Chains who may have further distributed the product throughout the United States.
- Type
- Voluntary: Firm initiated
- Recall initiated
- December 31, 2018
Related products
- Amlodipine And Valsartan – drug information
- NDC 65862-738 Amlodipine and valsartan · Amlodipine Besylate 5 mg/1; Valsartan 320 mg/1 · Aurobindo Pharma Limited
- NDC 65862-737 Amlodipine and valsartan · Amlodipine Besylate 5 mg/1; Valsartan 160 mg/1 · Aurobindo Pharma Limited
- NDC 65862-739 Amlodipine and valsartan · Amlodipine Besylate 10 mg/1; Valsartan 160 mg/1 · Aurobindo Pharma Limited
- NDC 65862-740 Amlodipine and valsartan · Amlodipine Besylate 10 mg/1; Valsartan 320 mg/1 · Aurobindo Pharma Limited