Amlodipine and Valsartan Tablets, USP 10/320 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., NDC 0378-1724-93.
Check against the official notice below — it lists the full affected range.
Mylan Laboratories is recalling Amlodipine and Valsartan Tablets USP 10/320 mg in 30-count bottles manufactured in India. The FDA confirmed that trace amounts of N-nitrosodiethylamine (NDEA), an impurity, were found in the active pharmaceutical ingredient used to make the product. The affected product was distributed throughout the United States and Puerto Rico to major distributors.
The recall involves 84,066 bottles with the following lot numbers: 3066064, 3069645, 3069646, 3073142, 3073143, 3073144, and 3077617. The product has NDC number 0378-1724-93. The source document does not specify what actions 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: 84,066 HDPE bottles Lot/code info: Lot Numbers: 3066064, 3069645, 3069646, 3073142, 3073143, 3073144, 3077617
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.