Drug recall D-1037-2019
Product
Valsartan Tablets USP 40 mg, 30 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-570-30
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: 470180008A, exp. date Feb 2020; 470180014A, 470180016A, exp. date Mar 2020; 470180032A, exp. date May 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