Why it was recalled
Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
Product description
Valsartan Tablets USP, 80 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 59746-361-90
Lot numbers, UPCs & expiration codes
Lot #: VR217013A, Exp. 08/2019
Where it was sold
Product was distributed throughout the United States to wholesalers and retailers.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1104-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Aug 14, 2018
- FDA report date
- Aug 29, 2018
- Quantity
- 9,552 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Jubilant Cadista Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-1104-2018, exactly as published.
Show all FDA fields
- City
- Salisbury
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 80836
- Address
- 207 Kiley Dr
- Code information
- Lot #: VR217013A, Exp. 08/2019
- Postal code
- 21801-2249
- Report date
- Aug 29, 2018
- Product type
- Drugs
- Recall number
- D-1104-2018
- Classification
- Class III
- Recalling firm
- Jubilant Cadista Pharmaceuticals, Inc.
- Product quantity
- 9,552 bottles
- Termination date
- Jan 8, 2020
- Reason for recall
- Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Valsartan Tablets USP, 80 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 59746-361-90
- Distribution pattern
- Product was distributed throughout the United States to wholesalers and retailers.
- Recall initiation date
- Aug 14, 2018
- Initial firm notification
- Letter
- Center classification date
- Aug 17, 2018