D-0318-2019 Class II Ongoing
FDA drug recall D-0318-2019 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: 48,302 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Dec 19, 2018
- Initiation Date
- Nov 20, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 48,302 bottles
Product Description
Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-1724-93.
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 # 3061986, exp. date 11/2018 Lot # 3079709, exp. date 1/2020 Lot # 3077618, exp. date 11/2019 Lot # 3079708, exp. date 1/2020
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0318-2019
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026