FDA-Drug2021-04-21Class II

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.

Jubilant Cadista Pharmaceuticals, Inc.
Hazard

Failed Dissolution Specifications

Sold states
Nationwide in the USA
Affected count
Lot #IT119008B - (4,128 Bottles); Lot #IT20001A - (3,984 Bottles); Lot #IT20002B - (4.080 Bottles)
Manufactured in
207 Kiley Dr, N/A, Salisbury, MD, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0333-2021

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