D-1039-2019 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- March 27, 2019
- Initiation Date
- December 31, 2018
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
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.
Distribution Pattern
Product was distributed to major distribution chains throughout the United States.
Code Information
Lot Numbers: 472180001A, 472180002A, 472180003A, 472180004A, exp. date Jan 2020; 472180007A, 472180008A, 472180009A, 472180010A, exp. date Mar 2020; 472180013A, 472180014A, exp. date Apr 2020