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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