Drug recall D-0322-2019
Product
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.
Lots and codes
Lot Numbers: 3064086, 3066061, 3066062,3073145,3073146,3073147, 3076091, 3077619, 3082432
Recall details
- Recalling firm
- Mylan Laboratories Limited, (Nashik FDF), Sinnar, Nashik District, N/A
- Quantity
- 109,314 HDPE bottles
- Distribution
- Product was distributed throughout the United States to several major distributors, including Puerto Rico.
- Type
- Voluntary: Firm initiated
- Recall initiated
- December 4, 2018
Related products
- Amlodipine And Valsartan – drug information
- NDC 0378-1722 Amlodipine And Valsartan · Amlodipine Besylate 10 mg/1; Valsartan 160 mg/1 · Mylan Pharmaceuticals Inc.
- NDC 0378-1721 Amlodipine And Valsartan · Amlodipine Besylate 5 mg/1; Valsartan 160 mg/1 · Mylan Pharmaceuticals Inc.
- NDC 0378-1723 Amlodipine And Valsartan · Amlodipine Besylate 5 mg/1; Valsartan 320 mg/1 · Mylan Pharmaceuticals Inc.
- NDC 0378-1724 Amlodipine And Valsartan · Amlodipine Besylate 10 mg/1; Valsartan 320 mg/1 · Mylan Pharmaceuticals Inc.