Recalls / Class II
Class IID-0333-2021
Product
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.
- Affected lot / code info
- Lot #s: IT119008B, Exp 05/2021; IT120001A, IT120002A, Exp 12/2021
Why it was recalled
Failed Dissolution Specifications
Recalling firm
- Firm
- Jubilant Cadista Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 207 Kiley Dr, N/A, Salisbury, Maryland 21801-2249
Distribution
- Quantity
- Lot #IT119008B - (4,128 Bottles); Lot #IT20001A - (3,984 Bottles); Lot #IT20002B - (4.080 Bottles)
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2021-04-01
- FDA classified
- 2021-04-12
- Posted by FDA
- 2021-04-21
- Terminated
- 2022-04-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0333-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.