Class II
Ongoing
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.
This recall is currently active, issued December 19, 2018. It was issued by Mylan Pharmaceuticals Inc..
- Company
- Mylan Pharmaceuticals Inc.
- Recall Initiated
- November 20, 2018
- Posted
- December 19, 2018
- Recall Number
- D-0316-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 25,147 bottles
- Firm Location
- Morgantown, WV, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Distribution
Product was distributed throughout the United States.
Lot / Code Info
Lot # 3081499, exp. date 3/2020 Lot # 3080009, exp. date 2/2020 Lot # 3080010, exp. date 2/2020 Lot # 3079205, exp. date 1/2020
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