Recalls / Class II
Class IID-0337-2024
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.
- Brand name
- Voriconazole
- Generic name
- Voriconazole
- Active ingredient
- Voriconazole
- Route
- Oral
- NDC
- 43386-038
- FDA application
- ANDA206799
- Affected lot / code info
- Lot#: S200756; Exp. 10/2024 Lot#: S300218; Exp. 04/2025 Lot#: S300633; Exp. 09/2025
Why it was recalled
Labeling: Incorrect or Missing Package Insert
Recalling firm
- Firm
- Lupin Pharmaceuticals Inc.
- Manufacturer
- Lupin Pharmaceuticals,Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- Harborplace Tower, 111 S Calvert St Fl 21st, Baltimore, Maryland 21202-6174
Distribution
- Quantity
- N/A
- Distribution pattern
- OH, IL, NJ
Timeline
- Recall initiated
- 2024-02-05
- FDA classified
- 2024-02-16
- Posted by FDA
- 2024-02-28
- Terminated
- 2024-12-27
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0337-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.