Drug recall D-0317-2019
Product
Valsartan and Hydrochlorothiazide Tablets, USP, 320 mg/25 mg, (a) 500-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A. NDC 0378-6325-05.
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 # 3084886, exp. date 2/2019 Lot # 3093804, exp. date 12/2019
Recall details
- Recalling firm
- Mylan Pharmaceuticals Inc., Morgantown, WV
- Quantity
- 5,660 bottles
- Distribution
- Product was distributed throughout the United States.
- Type
- Voluntary: Firm initiated
- Recall initiated
- November 20, 2018
Related products
- Valsartan and Hydrochlorothiazide – drug information
- NDC 0378-6325 Valsartan and Hydrochlorothiazide · Valsartan 320 mg/1; Hydrochlorothiazide 25 mg/1 · Mylan Pharmaceuticals Inc.
- NDC 0378-6323 Valsartan and Hydrochlorothiazide · Valsartan 160 mg/1; Hydrochlorothiazide 25 mg/1 · Mylan Pharmaceuticals Inc.
- NDC 0378-6321 Valsartan and Hydrochlorothiazide · Valsartan 80 mg/1; Hydrochlorothiazide 12.5 mg/1 · Mylan Pharmaceuticals Inc.
- NDC 0378-6324 Valsartan and Hydrochlorothiazide · Valsartan 320 mg/1; Hydrochlorothiazide 12.5 mg/1 · Mylan Pharmaceuticals Inc.
- NDC 0378-6322 Valsartan and Hydrochlorothiazide · Valsartan 160 mg/1; Hydrochlorothiazide 12.5 mg/1 · Mylan Pharmaceuticals Inc.