AMPHOTERICIN B Recall D-0493-2024
Description: Amphotericin B Liposome for Injection, 50mg vials, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Medicare Limited, Baska Ujeti Road, Ujeti Halol-389350, Gujarat, India. NDC 62756-233-01
AMPHOTERICIN B Recall D-0493-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0493-2024 |
| Event ID | 94442 |
| Brand | AMPHOTERICIN B |
| Generic Name | AMPHOTERICIN B |
| Manufacturer | AMPHOTERICIN B |
| Original Package? | 1 |
| Active Substance | AMPHOTERICIN B |
| Drug Route | INTRAVENOUS |
| Distribution | Nationwide within the United States |
| Quantity | 11,016 vials |
| Recall Reason | Out of specification for assay |
| Drug Classification | Class II |
| Drug Code Info | 20240515 |
| Product NDC | 62756-233 |
| Product NUI | N0000175510 N0000175498 M0017172 |
| Drug UPC | 0362756233010 |
| Pharma Class (EPC) | Lipid-based Polyene Antifungal [EPC] |
| Pharma Class (CS) | Polyenes [CS] |
| Recall Initiation Date | 20240419 |
| Report Date | 20240515 |
| Classification Date | 20240508 |
| Address | 2 Independence WayN/A Princeton, NJ 08540-6620 United States |
| Recalling Firm | SUN PHARMACEUTICAL INDUSTRIES INC |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 7XU7A7DROE |
| Drug Application Number | ANDA212514 |
| Structured Product Labeling (SPL ID) | 608db2b7-39be-47ea-acd0-0a37dc2cd0df |
| Structured Product Labeling (SPL Set ID) | 593cffa0-c305-48b6-8ec7-331e0ff91d2b |
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