Recalls / Class III
Class IIID-1105-2018
Product
Valsartan Tablets USP, 160 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilant Cardista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-362-90
- Brand name
- Valsartan
- Generic name
- Valsartan
- Active ingredient
- Valsartan
- Route
- Oral
- NDCs
- 59746-360, 59746-361, 59746-362, 59746-363
- FDA application
- ANDA203536
- Affected lot / code info
- Lot #: VR317040A, VR317041A, VR317042A, VR317043A, Exp. 08/2019
Why it was recalled
Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
Recalling firm
- Firm
- Jubilant Cadista Pharmaceuticals, Inc.
- Manufacturer
- Jubilant Cadista Pharmacuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 207 Kiley Dr, Salisbury, Maryland 21801-2249
Distribution
- Quantity
- 18,947 bottles
- Distribution pattern
- Product was distributed throughout the United States to wholesalers and retailers.
Timeline
- Recall initiated
- 2018-08-14
- FDA classified
- 2018-08-17
- Posted by FDA
- 2018-08-29
- Terminated
- 2020-01-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1105-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.