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.
Check against the official notice below — it lists the full affected range.
Mylan Laboratories Limited is recalling Amlodipine and Valsartan Tablets, USP 5/320 mg in 30-count bottles manufactured in India. The FDA confirmed the presence of trace amounts of an impurity called N-nitrosodiethylamine (NDEA) in the active pharmaceutical ingredient used to make the product. A total of 109,314 bottles were distributed throughout the United States and Puerto Rico across several major distributors, affecting lot numbers 3064086, 3066061, 3066062, 3073145, 3073146, 3073147, 3076091, 3077619, and 3082432.
The source document does not specify what actions affected consumers should take regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
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. Quantity: 109,314 HDPE bottles Lot/code info: Lot Numbers: 3064086, 3066061, 3066062,3073145,3073146,3073147, 3076091, 3077619, 3082432
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.