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FDARecalled Feb 28, 2024 · #D-0337-2024

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 vigorousl...

Hazard

Class II — temporary health risk

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Description

Labeling: Incorrect or Missing Package Insert Classification: Class II Distribution: OH, IL, NJ

Product 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.
Type
Drugs
Manufacturer
Lupin Pharmaceuticals Inc.
Model numbers
S200756, S300218, S300633
UPCs