Recall: D-0337-2024

Class II - Potentially Harmful

Class IIClassification

2024-02-05Initiated

TerminatedStatus

Lupin Pharmaceuticals Inc.Firm

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

Labeling: Incorrect or Missing Package Insert

Distribution

OH, IL, NJ

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.