Valsartan Tablets USP recalled over undeclared excipient
- Recall date
- May 25, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Jubilant Cadista Pharmaceuticals, Inc. recalls Valsartan Tablets USP, 320 mg, 90 tablet, Rx Only, Manufactured by: Jubilant Generics Ltd. Roorkee - 247661, India, Mar…
- Recall number
- D-0876-2018
- FDA classification
- Class III
- Brand / firm
- Jubilant Cadista Pharmaceuticals, Inc.
- Sold / distributed
- IN, MI, MS, NC, NJ, NY and OH
Why it was recalled
Incorrect/Undeclared excipient: Product batches were released into commercial distribution with a larger size grade of excipient (Crospovidone).
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
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
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