Recalls / Class II
Class IID-0327-2019
Product
Valsartan Tablets, USP 320 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-5815-77.
- Brand name
- Valsartan
- Generic name
- Valsartan
- Active ingredient
- Valsartan
- Route
- Oral
- NDCs
- 0378-5807, 0378-5813, 0378-5814, 0378-5815
- FDA application
- ANDA090866
- Affected lot / code info
- Lot Numbers: 3063783 3063784 3063785 3064092 3064093 3064094 3070349 3070350 3070351 3070352 3070353 3070354 3079030 3079031 3079032 3079033 3080011 3080224 3081498 3081500 3087126 3088476
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
- 129,754 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-0327-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.