Drug 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.
D-0337-2024
Product summary
- Event
- Event 93934
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0337-2024
Official wording
Reason: Labeling: Incorrect or Missing Package Insert
Code information: Lot#: S200756; Exp. 10/2024 Lot#: S300218; Exp. 04/2025 Lot#: S300633; Exp. 09/2025
Distribution pattern: OH, IL, NJ
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect or Missing