Recalls / Class III
Class IIID-0876-2018
Product
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
- 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 #: VR417065A, VR417066A, Exp 10/2019
Why it was recalled
Incorrect/Undeclared excipient: Product batches were released into commercial distribution with a larger size grade of excipient (Crospovidone).
Recalling firm
- Firm
- Jubilant Cadista Pharmaceuticals, Inc.
- Manufacturer
- Jubilant Cadista Pharmacuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 207 Kiley Dr, N/A, Salisbury, Maryland 21801-2249
Distribution
- Quantity
- 2,328 bottles (Lot VR417065A) and 2,352 bottles (Lot VR417066A)
- Distribution pattern
- IN, MI, MS, NC, NJ, NY and OH
Timeline
- Recall initiated
- 2018-05-25
- FDA classified
- 2018-06-15
- Posted by FDA
- 2018-06-13
- Terminated
- 2020-01-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0876-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.