Drug 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.
D-0333-2021
Product summary
- Event
- Event 87667
- Status
- Terminated
- Classification
- Class II
- Quantity
- Lot #IT119008B - (4,128 Bottles); Lot #IT20001A - (3,984 Bottles); Lot #IT20002B - (4.080 Bottles)
- Official record key
drug-enforcement:D-0333-2021
Official wording
Reason: Failed Dissolution Specifications
Code information: Lot #s: IT119008B, Exp 05/2021; IT120001A, IT120002A, Exp 12/2021
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications