D-1036-2019 Class II Ongoing
FDA drug recall D-1036-2019 was initiated by Aurobindo Pharma USA Inc. on Dec 31, 2018 and is designated Class II. 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. The recall status is ongoing.
Recall Details
- Product Type
- Drugs
- Report Date
- Mar 27, 2019
- Initiation Date
- Dec 31, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
Product Description
Amlodipine and Valsartan Tablets USP 10mg/160mg, 30 count bottles, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ Manufactured by: Aurobindo Pharma Limited, India --- NDC 65862-739-30
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.
Distribution Pattern
Product was distributed to major distribution chains throughout the United States.
Code Information
Lot Numbers: VFSA17007-A, exp. date Oct-2019
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1036-2019
- openFDA file date
- Oct 19, 2026
- Loaded by RegDataLab
- Oct 21, 2026