D-0337-2024Class II

Lupin Pharmaceuticals Inc.

Recalling firm

Product type

Drug

Status

Terminated

Report date

2024-02-28

Distribution

OH, IL, NJ

Firm state

Product quantity

N/A

Initiated by

Voluntary: Firm initiated

SPEQ quality domain

Documentation & Change Control

Reason for recall

Labeling: Incorrect or Missing Package Insert

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.

Code / lot info

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

Other recalls SPEQ maps to Documentation & Change Control

2026-07-22Class IIDaavlin Distributing Company 2026-07-22Class ID'Dioses Fruit Pops, Inc.2026-07-22Class ID'Dioses Fruit Pops, Inc.2026-07-22Class IIChocolate Bar Holdings LLC

See all Documentation & Change Control recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.