Jubilant Cadista Pharmaceuticals, Inc. recalls Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg*, 90-count bottle, Rx only, Manufactured by: Jubilant Generics…
- Recall date
- October 2, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0011-2019
- FDA classification
- Class II
- Brand / firm
- Jubilant Cadista Pharmaceuticals, Inc.
- Sold / distributed
- Product was distributed Nationwide in the USA and Puerto Rico.
Why it was recalled
Discoloration: Presence of dark discoloration or brown spots on the edges of the tablets.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg*, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd., Roorkee - 247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801; NDC 59746-284-90.
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