Voriconazole Oral Suspension Recalled for Missing Package Insert
Lupin Pharmaceuticals recalls Voriconazole for Oral Suspension (40mg/mL) due to missing or incorrect package inserts on affected batches distributed in Ohio, Illinois, and New Jersey.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves missing or incorrect medication labeling. While no illnesses or injuries have been reported, the missing package insert creates a significant risk of patient harm by preventing access to critical safety information required for proper use of this prescription medication.
Plain-English summary
Lupin Pharmaceuticals Inc. is recalling Voriconazole for Oral Suspension, 40mg/mL orange-flavored formulation (NDC 43386-038-60), manufactured by Novel Laboratories Inc. in Somerset, New Jersey. The recall affects three specific lots: S200756 (expires 10/2024), S300218 (expires 04/2025), and S300633 (expires 09/2025).
The product is being recalled because some packages are missing the required package insert or contain incorrect package insert information. The package insert provides essential information for safe medication use, including directions, warnings, and other safety-related guidance.
The affected product was distributed to pharmacies in Ohio, Illinois, and New Jersey. Patients or healthcare providers with affected bottles should contact their pharmacist to confirm whether their supply is involved and to obtain correct prescribing or usage information.
Patients should not discard the medication without consulting their healthcare provider, as this could affect their treatment. Further information about this recall is available from the FDA or Lupin Pharmaceuticals Inc.
The recalled product
- Product
- VORICONAZOLE (VORICONAZOLE)
- Brand
- VORICONAZOLE
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug
- Hazard
- labeling-error
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 (4)
- Lot#: S200756
- Exp. 10/2024 Lot#: S300218
- Exp. 04/2025 Lot#: S300633
- Exp. 09/2025
Distribution
Distributed in 3 states:
- IL
- NJ
- OH
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