Why it was recalled
Failed Dissolution Specifications
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.
Lot numbers, UPCs & expiration codes
Lot #s: IT119008B, Exp 05/2021; IT120001A, IT120002A, Exp 12/2021
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0333-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 1, 2021
- FDA report date
- Apr 21, 2021
- Quantity
- Lot #IT119008B - (4,128 Bottles); Lot #IT20001A - (3,984 Bottles); Lot #IT20002B - (4.080 Bottles)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Jubilant Cadista Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0333-2021, exactly as published.
Show all FDA fields
- City
- Salisbury
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 87667
- Address
- 207 Kiley Dr
- Code information
- Lot #s: IT119008B, Exp 05/2021; IT120001A, IT120002A, Exp 12/2021
- Postal code
- 21801-2249
- Report date
- Apr 21, 2021
- Product type
- Drugs
- Recall number
- D-0333-2021
- Classification
- Class II
- Recalling firm
- Jubilant Cadista Pharmaceuticals, Inc.
- Product quantity
- Lot #IT119008B - (4,128 Bottles); Lot #IT20001A - (3,984 Bottles); Lot #IT20002B - (4.080 Bottles)
- Termination date
- Apr 28, 2022
- Reason for recall
- Failed Dissolution Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Apr 1, 2021
- Initial firm notification
- Letter
- Center classification date
- Apr 12, 2021