D-0361-2019 Class II Ongoing
FDA drug recall D-0361-2019 was initiated by Aurobindo Pharma USA Inc. on Dec 31, 2018 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 18,408 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Jan 23, 2019
- Initiation Date
- Dec 31, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18,408 bottles
Product Description
Amlodipine and Valsartan Tablets USP 5 mg/160 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-737-30
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 Pattern
Product was distributed to 25 distributors and Retail Chains who may have further distributed the product throughout the United States.
Code Information
Lot # VESA17013-A, exp. 10/2019 Lot # VESA17014-A, exp. 10/2019 Lot # VESA18001-A, exp. 12/2019 Lot # VESA18002-A, exp. 12/2019
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0361-2019
- openFDA file date
- Oct 19, 2026
- Loaded by RegDataLab
- Oct 21, 2026