D-0493-2024 Class II Ongoing
FDA drug recall D-0493-2024 was initiated by SUN PHARMACEUTICAL INDUSTRIES INC on Apr 19, 2024 and is designated Class II. Reason for recall: Out of specification for assay The recall status is ongoing. Affected quantity: 11,016 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- May 15, 2024
- Initiation Date
- Apr 19, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11,016 vials
Product 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
Reason for Recall
Out of specification for assay
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: BAE0055A, BAE0056A, BAE0068A, Exp. Date 03/2026
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0493-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026