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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