Product Safety Recalls

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CEFDINIR Recall D-0518-2024

Description: Cefdinir for Oral Suspension USP, 250 mg/5 mL, packaged in a 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, Manufactured by: Lupin Limited, Mandideep, 462 046 India, NDC 68180-723-04

CEFDINIR Recall D-0518-2024 Information

Mandated?Voluntary: Firm initiated
Recall NumberD-0518-2024
Event ID94602
Generic NameCEFDINIR
Original Package?1
Active SubstanceCEFDINIR
Drug RouteORAL
DistributionUSA Nationwide
Quantity51,006 bottles
Recall ReasonDefective container: lack of seal integrity.
Drug ClassificationClass II
Drug Code Info20240605
Product NDC68180-722 68180-723
Product NUIN0000175488 M0003827
Pharma Class (EPC)Cephalosporin Antibacterial [EPC]
Pharma Class (CS)Cephalosporins [CS]
Recall Initiation Date20240508
Report Date20240605
Classification Date20240529
AddressHarborplace Tower111 S Calvert St Fl 21st
Baltimore, MD 21202-6174
United States
Recalling FirmLupin Pharmaceuticals Inc.
Initial Notification Letter
Unique Ingredient IdentifierCI0FAO63WC
Drug Application NumberANDA065259
Structured Product Labeling (SPL ID)63353f80-7738-4179-8947-509e71c34033
Structured Product Labeling (SPL Set ID)7490df67-56c0-4a1c-8533-2107f3e8aea5
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