Drug recall D-0337-2024

Class II Terminated reported Feb 28, 2024

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.

Reason for recall

Labeling: Incorrect or Missing Package Insert

Lots and codes

Lot#: S200756; Exp. 10/2024 Lot#: S300218; Exp. 04/2025 Lot#: S300633; Exp. 09/2025

Recall details

Recalling firm
Lupin Pharmaceuticals Inc., Baltimore, MD
Quantity
N/A
Distribution
OH, IL, NJ
Type
Voluntary: Firm initiated
Recall initiated
February 5, 2024
Terminated
December 27, 2024

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