Drug recall D-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
Reason for recall
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Lots and codes
Lot Numbers: VFSA17007-A, exp. date Oct-2019
Recall details
- Recalling firm
- Aurobindo Pharma USA Inc., East Windsor, NJ
- Quantity
- N/A
- Distribution
- Product was distributed to major distribution chains throughout the United States.
- Type
- Voluntary: Firm initiated
- Recall initiated
- December 31, 2018
Related products
- Amlodipine And Valsartan – drug information
- NDC 65862-738 Amlodipine and valsartan · Amlodipine Besylate 5 mg/1; Valsartan 320 mg/1 · Aurobindo Pharma Limited
- NDC 65862-737 Amlodipine and valsartan · Amlodipine Besylate 5 mg/1; Valsartan 160 mg/1 · Aurobindo Pharma Limited
- NDC 65862-739 Amlodipine and valsartan · Amlodipine Besylate 10 mg/1; Valsartan 160 mg/1 · Aurobindo Pharma Limited
- NDC 65862-740 Amlodipine and valsartan · Amlodipine Besylate 10 mg/1; Valsartan 320 mg/1 · Aurobindo Pharma Limited