FDA recall D-0337-2024

Lupin Pharmaceuticals Inc. · Class II · 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.

Reason for recall

Labeling: Incorrect or Missing Package Insert

Distribution

OH, IL, NJ

Key facts

Status
Terminated
Initiation date
2024-02-05
Report date
2024-02-28
Termination date
2024-12-27
Voluntary/Mandated
Voluntary: Firm initiated
Location
Baltimore, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0337-2024