Voriconazole Powder, For Suspension
FDA Recall NDC 43386-038
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Voriconazole (NDC 43386-038). A significant event, classified as Class II, was initiated on Feb 05, 2024 by Lupin Pharmaceuticals,inc.. The reported reason for this action was: "Labeling: Incorrect or Missing Package Insert"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Labeling: Incorrect or Missing Package Insert
Feb 05, 2024
Feb 28, 2024
N/A
Recall Profile & Regulatory Data
Event ID
93934
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
OH, IL, NJ
Termination Date
Dec 27, 2024
Product Description
Voriconazole for Oral Suspension, 40mg/mL, Orange-Flavored, 49g/75mL when reconstituted. Mixing Directions: Tap the bottle to release the powder. Add 50mL of water to the bottle and shake vigorously for 1 minute. Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873. Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, MD 21202. NDC: 43386-038-60.
Batch or Lot Expiration Information
Lot# : S200756; Exp. 10/2024
Lot# : S300218; Exp. 04/2025
Lot# : S300633; Exp. 09/2025
Affected Packages Involved in this Recall
43386-038-60Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
