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Class II · ModerateRecall completed

Voriconazole

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot#: S200756; Exp. 10/2024 Lot#: S300218; Exp. 04/2025 Lot#: S300633; Exp. 09/2025
Where it was soldOH, IL, NJ
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Labeling: Incorrect or Missing Package Insert

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byNovel Laboratories, Inc. Somerset, NJ 08873. Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, MD 21202
Brand nameVORICONAZOLE
Generic nameVORICONAZOLE
Active ingredient(s)VORICONAZOLE
Distributed by / forLupin Pharmaceuticals Inc. Baltimore, MD 21202
NDC43386-038-60
Show the full FDA record
Full product labelVoriconazole 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 firmLupin Pharmaceuticals Inc.
DistributionOH, IL, NJ
QuantityN/A
Recall initiated2024-02-05
Report date2024-02-28
Recall completed2024-12-27
Recall numberD-0337-2024
ClassificationClass II
FDA statusTerminated
Origin on fileBaltimore MD United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.