Class II
Ongoing
Valsartan Tablets USP 80 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-571-90
This recall is currently active, issued March 27, 2019. It was issued by Aurobindo Pharma Usa Inc..
- Company
- Aurobindo Pharma Usa Inc.
- Recall Initiated
- December 31, 2018
- Posted
- March 27, 2019
- Recall Number
- D-1038-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Firm Location
- East Windsor, NJ, United States
- Official Source
- View on FDA website ↗
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
Product was distributed to major distribution chains throughout the United States.
Lot / Code Info
Lot Numbers: 471170015A, exp. date Sep 2019; 471180004A, 471180005A, exp. date Feb 2019
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