D-0329-2019 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- December 19, 2018
- Initiation Date
- December 4, 2018
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 50,595 HDPE bottles
Product Description
Valsartan and Hydrochlorothiazide Tablets, USP 160/12.5 mg, (a) 90-count bottle (NDC 0378-6322-77), (b) 500-count bottles (NDC 0378-6322-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A.
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 Pattern
Product was distributed throughout the United States to several major distributors, including Puerto Rico.
Code Information
Lot numbers: 2008880 3084358 3084359 3093801 3084359 3084361 3093801