D-0322-2019 Class II Ongoing
FDA drug recall D-0322-2019 was initiated by Mylan Laboratories Limited, (Nashik FDF) on December 4, 2018 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 109,314 HDPE bottles.
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
- 109,314 HDPE bottles
Product Description
Amlodipine and Valsartan Tablets, USP 5/320 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-1723-93.
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: 3064086, 3066061, 3066062,3073145,3073146,3073147, 3076091, 3077619, 3082432