Drug & medication recalls Moderate risk

Jubilant Cadista Pharmaceuticals, Inc. recalls Itraconazole Capsules, 100 mg, 30-count bottles, Rx only, Manufactured by: Jubilant Generics Ltd., Roorkee - 247661, In…

Recall date
April 1, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0333-2021
FDA classification
Class II
Brand / firm
Jubilant Cadista Pharmaceuticals, Inc.
Sold / distributed
Nationwide in the USA

Why it was recalled

Failed Dissolution Specifications

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Itraconazole Capsules, 100 mg, 30-count bottles, Rx only, Manufactured by: Jubilant Generics Ltd., Roorkee - 247661, India; Marketed by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD 21801, NDC 59746-282-30.

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