Recalls / Class II
Class IID-0312-2019
Product
Amlodipine and Valsartan Tablets, USP,10 mg/160 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-1722-93.
- 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 # 3079500, exp. date 1/2020
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
- 12,336 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-0312-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.