Class IITerminated

Voriconazole for Oral Suspension recall

FDA recall D-0337-2024 · initiated Feb 5, 2024

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

Labeling: Incorrect or Missing Package Insert

Details

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.
Recalling company: Lupin Pharms
Classification: Class II
Status: Terminated
Type: Voluntary: Firm initiated
Distribution: OH, IL, NJ
Initiated: Feb 5, 2024
FDA report date: Feb 28, 2024

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0337-2024 ↗

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