Why it was recalled
Incorrect/Undeclared excipient: Product batches were released into commercial distribution with a larger size grade of excipient (Crospovidone).
Product description
Valsartan Tablets USP, 320 mg, 90 tablet, Rx Only, Manufactured by: Jubilant Generics Ltd. Roorkee - 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD 21801, NDC 59746-363-90
Lot numbers, UPCs & expiration codes
Lot #: VR417065A, VR417066A, Exp 10/2019
Where it was sold
IN, MI, MS, NC, NJ, NY and OH
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-0876-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- May 25, 2018
- FDA report date
- Jun 13, 2018
- Quantity
- 2,328 bottles (Lot VR417065A) and 2,352 bottles (Lot VR417066A)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Jubilant Cadista Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0876-2018, exactly as published.
Show all FDA fields
- City
- Salisbury
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 80133
- Address
- 207 Kiley Dr
- Code information
- Lot #: VR417065A, VR417066A, Exp 10/2019
- Postal code
- 21801-2249
- Report date
- Jun 13, 2018
- Product type
- Drugs
- Recall number
- D-0876-2018
- Classification
- Class III
- Recalling firm
- Jubilant Cadista Pharmaceuticals, Inc.
- Product quantity
- 2,328 bottles (Lot VR417065A) and 2,352 bottles (Lot VR417066A)
- Termination date
- Jan 8, 2020
- Reason for recall
- Incorrect/Undeclared excipient: Product batches were released into commercial distribution with a larger size grade of excipient (Crospovidone).
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Valsartan Tablets USP, 320 mg, 90 tablet, Rx Only, Manufactured by: Jubilant Generics Ltd. Roorkee - 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD 21801, NDC 59746-363-90
- Distribution pattern
- IN, MI, MS, NC, NJ, NY and OH
- Recall initiation date
- May 25, 2018
- Initial firm notification
- Letter
- Center classification date
- Jun 15, 2018