May 2023 FDA Recall Drug by Sun Pharmaceutical Industries Inc
D-0891-2023 - Subpotent drug

This Class II drug recall was initiated by Sun Pharmaceutical Industries Inc on May 30, 2023 for the product Drug. The FDA reported the reason for recall as subpotent drug. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0891-2023

Reason for Recall
Subpotent drug
Initiated
05-30-2023
Reported
07-05-2023
Quantity
12960 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
92425
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
N/A
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-18-2023
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# BAD0089A, Exp 01/2025; BAD0330A, Exp 07/2025