Recalls / Class II
Class IID-0320-2019
Product
Amlodipine and Valsartan Tablets, USP 5/160 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-1721-93.
- Brand name
- Amlodipine And Valsartan
- Generic name
- Amlodipine And Valsartan
- Active ingredients
- Amlodipine Besylate, Valsartan
- Route
- Oral
- NDCs
- 0378-1721, 0378-1722, 0378-1723, 0378-1724
- FDA application
- ANDA090483
- Affected lot / code info
- Lot Numbers:3064084, 3069629, 3073148, 3073149,3076093, 3077772
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
- 141,995 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-0320-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.