Recalls / Class II
Class IID-0331-2019
Product
Valsartan and Hydrochlorothiazide Tablets, USP 320/12.5 mg, (a) 90-count bottle (NDC 0378-6324-77), (b) 500-count bottles (NDC 0378-6324-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A.
- 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 numbers: 3084889 3084890 3093803
Why it was recalled
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Recalling firm
- Firm
- Mylan Laboratories Limited, (Nashik FDF)
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- F-4 F-12, Malegaon M.I.D.C., Sinnar, N/A, Sinnar, Nashik District, N/A N/A, India
Distribution
- Quantity
- 19,352 HDPE bottles
- Distribution pattern
- Product was distributed throughout the United States to several major distributors, including Puerto Rico.
Timeline
- Recall initiated
- 2018-12-04
- FDA classified
- 2018-12-14
- Posted by FDA
- 2018-12-19
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0331-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.