Drug recall D-0329-2019
Product
Valsartan and Hydrochlorothiazide Tablets, USP 160/12.5 mg, (a) 90-count bottle (NDC 0378-6322-77), (b) 500-count bottles (NDC 0378-6322-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A.
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: 2008880 3084358 3084359 3093801 3084359 3084361 3093801
Recall details
- Recalling firm
- Mylan Laboratories Limited, (Nashik FDF), Sinnar, Nashik District, N/A
- Quantity
- 50,595 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
- 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.