Drug Enforcement D-0493-2024

Out of specification for assay

Status

Ongoing

Classification

Class II

Report Date

May 15, 2024

Termination Date

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Product Information

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
Product quantity
11,016 vials
Reason for recall
Out of specification for assay
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide within the United States

Location & Firm

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

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0493-2024
Event ID
94442
Recall initiation date
April 19, 2024
Center classification date
May 8, 2024
Code info
Lot #: BAE0055A, BAE0056A, BAE0068A, Exp. Date 03/2026
More code info
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