Drug recall D-0370-2019
Product
Valsartan tablets USP 320 mg, 90-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-573-90.
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 # VUSD17008-A, exp. date 07/2019 Lot # VUSD17009-A, exp. date 09/2019
Recall details
- Recalling firm
- Aurobindo Pharma USA Inc., East Windsor, NJ
- Quantity
- 20,604 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
- Valsartan – drug information
- NDC 65862-572 Valsartan · Valsartan 160 mg/1 · Aurobindo Pharma Limited
- NDC 65862-571 Valsartan · Valsartan 80 mg/1 · Aurobindo Pharma Limited
- NDC 65862-573 Valsartan · Valsartan 320 mg/1 · Aurobindo Pharma Limited
- NDC 65862-570 Valsartan · Valsartan 40 mg/1 · Aurobindo Pharma Limited