FDAFDA · Food and drugs·Recall number D-0493-2024
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
Published May 15, 2024 · Recall initiated: April 19, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Out of specification for assay
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- AMPHOTERICIN B
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Distributor
- Nationwide within the United States
- UPC
- 0362756233010
- Lot
- Lot #: BAE0055A, BAE0056A, BAE0068A, Exp. Date 03/2026
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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