Drug Enforcement D-0648-2024

Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.

Status

Terminated

Classification

Class II

Report Date

September 4, 2024

Termination Date

April 29, 2025

Product Information

Product description
Cefixime for Oral Suspension USP, 100 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-405-01
Product quantity
4554 bottles
Reason for recall
Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
USA nationwide.

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-0648-2024
Event ID
95193
Recall initiation date
August 21, 2024
Center classification date
August 26, 2024
Code info
Lot #: F201517, Exp 11/30/2024
More code info
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