Drug Enforcement D-0559-2024

Failed Content Uniformity Specifications

Status

Terminated

Classification

Class II

Report Date

June 26, 2024

Termination Date

April 29, 2025

Product Information

Product description
Cefixime for Oral Suspension USP 200 mg/5 mL (50 mL Pack size), Powder for oral suspension, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore Maryland, Manufactured by: Lupin Limited, Mandideep, India NDC 68180-407-03
Product quantity
3,552 bottles
Reason for recall
Failed Content Uniformity Specifications
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the US

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-0559-2024
Event ID
94723
Recall initiation date
May 30, 2024
Center classification date
June 18, 2024
Code info
Lot F201519, Expiry: November 2024
More code info
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