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.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot #s: IT119008B, Exp 05/2021; IT120001A, IT120002A, Exp 12/2021
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Jubilant Cadista Pharmaceuticals, Inc.
Reason for Recall:
Failed Dissolution Specifications
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full 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.

Product Codes/Lot Numbers:

Lot #s: IT119008B, Exp 05/2021; IT120001A, IT120002A, Exp 12/2021

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0333-2021

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