February 2024 FDA Recall Voriconazole by Lupin Pharmaceuticals Inc.
D-0337-2024 - Labeling

This Class II drug recall was voluntarily initiated by Lupin Pharmaceuticals Inc. on February 5, 2024 for the product Voriconazole. The FDA reported the reason for recall as labeling. The product was distributed in OH, IL, NJ and the recall is currently terminated.

Recall Number: D-0337-2024

Reason for Recall
Labeling: Incorrect or Missing Package Insert
Initiated
02-05-2024
Reported
02-28-2024
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
93934
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Lupin Pharmaceuticals Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
OH, IL, NJ
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-27-2024
Product Description About Product Description
Full technical description of the product.
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

43386-038-60 Voriconazole