D-0316-2019 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- December 19, 2018
- Initiation Date
- November 20, 2018
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 25,147 bottles
Product Description
Valsartan Tablets, USP, 320 mg, 90-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-5815-77.
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 # 3081499, exp. date 3/2020 Lot # 3080009, exp. date 2/2020 Lot # 3080010, exp. date 2/2020 Lot # 3079205, exp. date 1/2020