Jubilant Cadista Recalls Itraconazole Capsules Due to Dissolution Failures
Jubilant Cadista Pharmaceuticals is recalling specific lots of Itraconazole Capsules, 100 mg, because they failed to meet dissolution specifications.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which indicates a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The source text does not report any illnesses or injuries, and the hazard is a quality failure (dissolution) rather than a direct physical danger like fire or choking.
Plain-English summary
Jubilant Cadista Pharmaceuticals, Inc. is recalling Itraconazole Capsules, 100 mg, 30-count bottles. The recall involves specific lots identified as IT119008B, IT120001A, and IT120002B. The product is a prescription-only medication manufactured by Jubilant Generics Ltd. in India and marketed by Jubilant Cadista Pharmaceuticals, Inc. in Salisbury, MD.
The recall was initiated because the affected lots failed to meet dissolution specifications. Dissolution is a critical quality attribute that ensures the medication releases the active ingredient at the appropriate rate for absorption in the body. Failure to meet these specifications may result in the medication not working as intended.
The affected products were distributed nationwide in the USA. Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed in the recall notice. If you have these products, you should stop using them and contact your pharmacist or healthcare provider for guidance on obtaining a replacement or alternative treatment.
The recalled product
- 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.
- Manufacturer
- Jubilant Cadista Pharmaceuticals, Inc.
- Category
- Drug — Antifungal
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lot #s: IT119008B
- Exp 05/2021
- IT120001A
- IT120002A
- Exp 12/2021
Distribution
Distributed nationwide across the United States.
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