Class II
Ongoing
Valsartan and Hydrochlorothiazide Tablets, USP 320/25 mg, (a) 90-count bottle (NDC 0378-6325-77), (b) 500-count bottles (NDC 0378-6325-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A.
This recall is currently active, issued December 19, 2018. It was issued by Mylan Laboratories Limited, (Nashik Fdf).
- Recall Initiated
- December 4, 2018
- Posted
- December 19, 2018
- Recall Number
- D-0332-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 32,284 HDPE bottles
- Firm Location
- Sinnar, Nashik District, India
- Official Source
- View on FDA website ↗
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
Product was distributed throughout the United States to several major distributors, including Puerto Rico.
Lot / Code Info
Lot numbers: 3084860 3084861 3084862 3093804 3084862 3084863
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