April 2024 FDA Recall Amphotericin B by Sun Pharmaceutical Industries Inc
D-0493-2024 - Out of specification for assay
This Class II drug recall was voluntarily initiated by Sun Pharmaceutical Industries Inc on April 19, 2024 for the product Amphotericin B. The FDA reported the reason for recall as out of specification for assay. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0493-2024
Out of specification for assay
04-19-2024
05-15-2024
11,016 vials
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the United States
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Batch or Lot Expiration Information
Lot# : BAE0055A, BAE0056A, BAE0068A, Exp. Date 03/2026
