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.
Reported: February 28, 2024 Initiated: February 5, 2024 #D-0337-2024
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.
Reason for Recall
Labeling: Incorrect or Missing Package Insert
Details
- Recalling Firm
- Lupin Pharmaceuticals Inc.
- Units Affected
- N/A
- Distribution
- OH, IL, NJ
- Location
- Baltimore, MD
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Lupin Pharmaceuticals Inc.. Units affected: N/A.
Why was this product recalled? ▼
Labeling: Incorrect or Missing Package Insert
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 28, 2024. Severity: Moderate. Recall number: D-0337-2024.
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