D-0327-2019 Class II Ongoing
FDA drug recall D-0327-2019 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: 129,754 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
- 129,754 HDPE bottles
Product Description
Valsartan Tablets, USP 320 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-5815-77.
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: 3063783 3063784 3063785 3064092 3064093 3064094 3070349 3070350 3070351 3070352 3070353 3070354 3079030 3079031 3079032 3079033 3080011 3080224 3081498 3081500 3087126 3088476