Drug recall D-0318-2019
Product
Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-1724-93.
Reason for recall
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Lots and codes
Lot # 3061986, exp. date 11/2018 Lot # 3079709, exp. date 1/2020 Lot # 3077618, exp. date 11/2019 Lot # 3079708, exp. date 1/2020
Recall details
- Recalling firm
- Mylan Pharmaceuticals Inc., Morgantown, WV
- Quantity
- 48,302 bottles
- Distribution
- Product was distributed throughout the United States.
- Type
- Voluntary: Firm initiated
- Recall initiated
- November 20, 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.