FDA-Drug2024-05-15Class II
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
Hazard
Out of specification for assay
Sold states
Nationwide within the United States
Affected count
11,016 vials
Manufactured in
2 Independence Way, N/A, Princeton, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0493-2024More SUN PHARMACEUTICAL INDUSTRIES INC recalls
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