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.
Reported: April 21, 2021 Initiated: April 1, 2021 #D-0333-2021
Product Description
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.
Reason for Recall
Failed Dissolution Specifications
Details
- Recalling Firm
- Jubilant Cadista Pharmaceuticals, Inc.
- Units Affected
- Lot #IT119008B - (4,128 Bottles); Lot #IT20001A - (3,984 Bottles); Lot #IT20002B - (4.080 Bottles)
- Distribution
- Nationwide in the USA
- Location
- Salisbury, MD
Frequently Asked Questions
What product 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.. Recalled by Jubilant Cadista Pharmaceuticals, Inc.. Units affected: Lot #IT119008B - (4,128 Bottles); Lot #IT20001A - (3,984 Bottles); Lot #IT20002B - (4.080 Bottles).
Why was this product recalled? ▼
Failed Dissolution Specifications
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 21, 2021. Severity: Moderate. Recall number: D-0333-2021.
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