Drug Enforcement D-0891-2023

Subpotent drug

Status

Terminated

Classification

Class II

Report Date

July 5, 2023

Termination Date

December 18, 2023

Product Information

Product description
Amphotericin B Liposome for Injection, 50mg/vial, 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 62756-0233-01
Product quantity
12960 vials
Reason for recall
Subpotent drug
Recall initiation reason
—
Initial firm notification
N/A
Distribution pattern
USA nationwide

Location & Firm

Recalling firm
SUN PHARMACEUTICAL INDUSTRIES INC
Address
2 Independence Way, N/A

United States
Voluntary / Mandated
N/A
Status date
—

Codes & Dates

Recall number
D-0891-2023
Event ID
92425
Recall initiation date
May 30, 2023
Center classification date
June 29, 2023
Code info
Lot # BAD0089A, Exp 01/2025; BAD0330A, Exp 07/2025
More code info
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