CEFIXIME Recall D-0559-2024
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
CEFIXIME Recall D-0559-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0559-2024 |
| Event ID | 94723 |
| Brand | CEFIXIME |
| Generic Name | CEFIXIME |
| Manufacturer | CEFIXIME |
| Original Package? | 1 |
| Active Substance | CEFIXIME |
| Drug Route | ORAL |
| Distribution | Nationwide in the US |
| Quantity | 3,552 bottles |
| Recall Reason | Failed Content Uniformity Specifications |
| Drug Classification | Class II |
| Drug Code Info | 20240626 |
| Product NDC | 68180-405 68180-407 68180-416 |
| Drug UPC | 0368180423119 0368180416081 0368180423089 |
| Recall Initiation Date | 20240530 |
| Report Date | 20240626 |
| Classification Date | 20240618 |
| 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 | 97I1C92E55 |
| Drug Application Number | ANDA065129 |
| Structured Product Labeling (SPL ID) | 8b1eb90e-2cfa-4ea7-b191-66017220852b |
| Structured Product Labeling (SPL Set ID) | 6d68dbd9-7d75-4ff1-91db-79ff8ae879ec |
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