FDA Drug recall D-0493-2024
Amphotericin B Liposome for Injection, 50mg vials, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc
- FDA Drug
- Class II
- ongoing
- Published 2024-05-15
On 2024-05-15 the FDA classified a Class II recall of Amphotericin B Liposome for Injection, 50mg vials, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc by Sun Pharmaceutical Industries, citing out of specification for assay.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0493-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-04-19 |
| Published | 2024-05-15 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sun Pharmaceutical Industries |
| Distribution | US |
Product
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
Reason
Out of specification for assay
Identifiers
| ndc | 62756-233-01 |
|---|---|
| ndc | 62756-233-02 |
| code_info | Lot #: BAE0055A, BAE0056A, BAE0068A, Exp. Date 03/2026 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0493-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.