D-0317-2019 Class II Ongoing
FDA drug recall D-0317-2019 was initiated by Mylan Pharmaceuticals Inc. on Nov 20, 2018 and is designated Class II. Reason for recall: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product. The recall status is ongoing. Affected quantity: 5,660 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Dec 19, 2018
- Initiation Date
- Nov 20, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,660 bottles
Product Description
Valsartan and Hydrochlorothiazide Tablets, USP, 320 mg/25 mg, (a) 500-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A. NDC 0378-6325-05.
Reason for Recall
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Distribution Pattern
Product was distributed throughout the United States.
Code Information
Lot # 3084886, exp. date 2/2019 Lot # 3093804, exp. date 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-0317-2019
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026