Recalls / Class II
Class IID-1036-2019
Product
Amlodipine and Valsartan Tablets USP 10mg/160mg, 30 count bottles, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ Manufactured by: Aurobindo Pharma Limited, India --- NDC 65862-739-30
- 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 Numbers: VFSA17007-A, exp. date Oct-2019
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
- Aurobindo Pharma USA Inc.
- Manufacturer
- Aurobindo Pharma Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 279 Princeton Hightstown Rd, N/A, East Windsor, New Jersey 08520-1401
Distribution
- Quantity
- N/A
- Distribution pattern
- Product was distributed to major distribution chains throughout the United States.
Timeline
- Recall initiated
- 2018-12-31
- FDA classified
- 2019-03-21
- Posted by FDA
- 2019-03-27
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-1036-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.