D-0321-2019 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
- 76,516 HDPE bottles
Product Description
Amlodipine and Valsartan Tablets, USP 10/160 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-1722-93.
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: 3064085, 3066063,3069638,3069639