Recalls / Class II
Class IID-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.
- Brand name
- Valsartan And Hydrochlorothiazide
- Generic name
- Valsartan And Hydrochlorothiazide
- Active ingredients
- Hydrochlorothiazide, Valsartan
- Route
- Oral
- NDCs
- 0378-6321, 0378-6322, 0378-6323, 0378-6324, 0378-6325
- FDA application
- ANDA078020
- Affected lot / code info
- Lot # 3084886, exp. date 2/2019 Lot # 3093804, exp. date 12/2019
Why it was recalled
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Recalling firm
- Firm
- Mylan Pharmaceuticals Inc.
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 781 Chestnut Ridge Rd, N/A, Morgantown, West Virginia 26505-2730
Distribution
- Quantity
- 5,660 bottles
- Distribution pattern
- Product was distributed throughout the United States.
Timeline
- Recall initiated
- 2018-11-20
- FDA classified
- 2018-12-14
- Posted by FDA
- 2018-12-19
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0317-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.