Drug recall D-1103-2018
Product
Valsartan Tablets USP, 40 mg, 30-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilant Cardista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-360-30
Reason for recall
Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
Lots and codes
Lot #: VR117014A, VR117015A, Exp. 08/2019
Recall details
- Recalling firm
- Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD
- Quantity
- 10,577 bottles
- Distribution
- Product was distributed throughout the United States to wholesalers and retailers.
- Type
- Voluntary: Firm initiated
- Recall initiated
- August 14, 2018
- Terminated
- January 8, 2020
Related products
- Valsartan – drug information
- NDC 59746-360 Valsartan · Valsartan 40 mg/1 · Jubilant Cadista Pharmaceuticals Inc.
- NDC 59746-361 Valsartan · Valsartan 80 mg/1 · Jubilant Cadista Pharmaceuticals Inc.
- NDC 59746-393 Valsartan · Valsartan 320 mg/1 · Jubilant Cadista Pharmaceuticals Inc.
- NDC 59746-362 Valsartan · Valsartan 160 mg/1 · Jubilant Cadista Pharmaceuticals Inc.