D-0493-2024 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- May 15, 2024
- Initiation Date
- April 19, 2024
- Termination Date
- N/A
- 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