Class II
Ongoing
Valsartan tablets USP 320 mg, 90-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-573-90.
- Company
- Aurobindo Pharma Usa Inc.
- Recall Initiated
- December 31, 2018
- Posted
- January 23, 2019
- Recall Number
- D-0370-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 20,604 bottles
- Firm Location
- East Windsor, NJ, United States
Reason for Recall
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Distribution
Product was distributed to 25 distributors and Retail Chains who may have further distributed the product throughout the United States.
Lot / Code Info
Lot # VUSD17008-A, exp. date 07/2019 Lot # VUSD17009-A, exp. date 09/2019
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