Voriconazole for Oral Suspension, 40mg/mL, Orange-Flavored, 49g/75mL when reconstituted. Mixing D...
FDA Recall #D-0337-2024 — Class II — February 5, 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.
Reason for Recall
Labeling: Incorrect or Missing Package Insert
Recalling Firm
Lupin Pharmaceuticals Inc. — Baltimore, MD
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
N/A
Distribution
OH, IL, NJ
Code Information
Lot#: S200756; Exp. 10/2024 Lot#: S300218; Exp. 04/2025 Lot#: S300633; Exp. 09/2025
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated