Drug Enforcement D-0337-2024

Labeling: Incorrect or Missing Package Insert

Status

Terminated

Classification

Class II

Report Date

February 28, 2024

Termination Date

December 27, 2024

Product Information

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.
Product quantity
N/A
Reason for recall
Labeling: Incorrect or Missing Package Insert
Recall initiation reason
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Initial firm notification
E-Mail
Distribution pattern
OH, IL, NJ

Location & Firm

Recalling firm
Lupin Pharmaceuticals Inc.
Address
Harborplace Tower, 111 S Calvert St Fl 21st

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0337-2024
Event ID
93934
Recall initiation date
February 5, 2024
Center classification date
February 16, 2024
Code info
Lot#: S200756; Exp. 10/2024 Lot#: S300218; Exp. 04/2025 Lot#: S300633; Exp. 09/2025
More code info
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