Drug recall D-1038-2019
Product
Valsartan Tablets USP 80 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-571-90
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.
Lots and codes
Lot Numbers: 471170015A, exp. date Sep 2019; 471180004A, 471180005A, exp. date Feb 2019
Recall details
- Recalling firm
- Aurobindo Pharma USA Inc., East Windsor, NJ
- Quantity
- N/A
- Distribution
- Product was distributed to major distribution chains 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