Recalls / Class II
Class IID-0363-2019
Product
Amlodipine and Valsartan Tablets USP 5 mg/320 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-738-30.
- Brand name
- Amlodipine And Valsartan
- Generic name
- Amlodipine And Valsartan
- Active ingredients
- Amlodipine Besylate, Valsartan
- Route
- Oral
- NDCs
- 65862-737, 65862-739, 65862-738, 65862-740
- FDA application
- ANDA206512
- Affected lot / code info
- Lot # VMSA17012-A, exp. date 11/2019 Lot # VMSA17013-A, exp. date 11/2019 Lot # VMSA17014-A, exp. date 11/2019 Lot # VMSA17015-A, exp. date 11/2019 Lot # VMSA17016-A, exp. date 11/2019 Lot # VMSA17017-A, exp. date 11/2019
Why it was recalled
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Recalling firm
- Firm
- Aurobindo Pharma USA Inc.
- Manufacturer
- Aurobindo Pharma Limited
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 279 Princeton Hightstown Rd, East Windsor, New Jersey 08520-1401
Distribution
- Quantity
- 27,688 bottles
- Distribution pattern
- Product was distributed to 25 distributors and Retail Chains who may have further distributed the product throughout the United States.
Timeline
- Recall initiated
- 2018-12-31
- FDA classified
- 2019-01-14
- Posted by FDA
- 2019-01-23
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0363-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.