Pantoprazole Sodium Delayed-Release Tablets recalled over manufacturing violations
- Recall date
- March 11, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Jubilant Cadista Pharmaceuticals, Inc. recalls Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg, 90 count bottle, Rx Only, Manufactured by Jubilant Generics Lt…
- Recall number
- D-1058-2020
- FDA classification
- Class II
- Brand / firm
- Jubilant Cadista Pharmaceuticals, Inc.
- Sold / distributed
- Distributed Nationwide in the USA
Why it was recalled
CGMP Deviations: Presence of dark brown discoloration on edges of 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, NDC 59746-284-90
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