Why it was recalled
Labeling: Incorrect or Missing Package Insert
Product description
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.
Lot numbers, UPCs & expiration codes
Lot#: S200756; Exp. 10/2024 Lot#: S300218; Exp. 04/2025 Lot#: S300633; Exp. 09/2025
Where it was sold
OH, IL, NJ
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0337-2024
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 5, 2024
- FDA report date
- Feb 28, 2024
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0337-2024, exactly as published.
Show all FDA fields
- City
- Baltimore
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 93934
- Address
- Harborplace Tower
- Address (line 2)
- 111 S Calvert St Fl 21st
- Code information
- Lot#: S200756; Exp. 10/2024 Lot#: S300218; Exp. 04/2025 Lot#: S300633; Exp. 09/2025
- Postal code
- 21202-6174
- Report date
- Feb 28, 2024
- Product type
- Drugs
- Recall number
- D-0337-2024
- Classification
- Class II
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Termination date
- Dec 27, 2024
- Reason for recall
- Labeling: Incorrect or Missing Package Insert
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- OH, IL, NJ
- Recall initiation date
- Feb 5, 2024
- Initial firm notification
- Center classification date
- Feb 16, 2024