Amantadine Hydrochloride Tablets recalled over foreign material
- Recall date
- December 2, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Jubilant Cadista Pharmaceuticals, Inc. recalls Amantadine Hydrochloride Tablets, 100 mg, 100-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd., Roorkee-2…
- Recall number
- D-0576-2020
- FDA classification
- Class II
- Brand / firm
- Jubilant Cadista Pharmaceuticals, Inc.
- Sold / distributed
- Nationwide in the USA.
Why it was recalled
Presence of Foreign Substance: Presence of a foreign object in a single tablet.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Amantadine Hydrochloride Tablets, 100 mg, 100-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd., Roorkee-247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, USA; NDC 59746-699-01.
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