CEFDINIR Recall D-0496-2024
Description: Cefdinir for Oral Suspension USP 250 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046, India, NDC 68180-723-04
CEFDINIR Recall D-0496-2024 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-0496-2024 |
Event ID | 94492 |
Brand | CEFDINIR |
Generic Name | CEFDINIR |
Manufacturer | CEFDINIR |
Original Package? | 1 |
Active Substance | CEFDINIR |
Drug Route | ORAL |
Distribution | USA nationwide |
Quantity | 17,070 bottles |
Recall Reason | Presence of foreign substance: Product complaint of foreign material in reconstituted bottle. |
Drug Classification | Class II |
Drug Code Info | 20240522 |
Product NDC | 68180-722 68180-723 |
Product NUI | N0000175488 M0003827 |
Pharma Class (EPC) | Cephalosporin Antibacterial [EPC] |
Pharma Class (CS) | Cephalosporins [CS] |
Recall Initiation Date | 20240424 |
Report Date | 20240522 |
Classification Date | 20240514 |
Address | Harborplace Tower111 S Calvert St Fl 21st Baltimore, MD 21202-6174 United States |
Recalling Firm | Lupin Pharmaceuticals Inc. |
Initial Notification | Letter |
Unique Ingredient Identifier | CI0FAO63WC |
Drug Application Number | ANDA065259 |
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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