Drug recall D-1039-2019
Product
Valsartan Tablets USP 160 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-572-90
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: 472180001A, 472180002A, 472180003A, 472180004A, exp. date Jan 2020; 472180007A, 472180008A, 472180009A, 472180010A, exp. date Mar 2020; 472180013A, 472180014A, exp. date Apr 2020
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