Class II
Ongoing
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
This recall is currently active, issued May 15, 2024. It was issued by Sun Pharmaceutical Industries Inc.
- Recall Initiated
- April 19, 2024
- Posted
- May 15, 2024
- Recall Number
- D-0493-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 11,016 vials
- Firm Location
- Princeton, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Out of specification for assay
Distribution
Nationwide within the United States
Lot / Code Info
Lot #: BAE0055A, BAE0056A, BAE0068A, Exp. Date 03/2026
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