FDA Recall D-0493-2024

SUN PHARMACEUTICAL INDUSTRIES INC · Princeton, NJ

Class II Ongoing 755 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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

Lot / code: Lot #: BAE0055A, BAE0056A, BAE0068A, Exp. Date 03/2026

Quantity: 11,016 vials

Reason for recall

Out of specification for assay

Recall record

Recall number: D-0493-2024
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide within the United States
Recall initiated: 2024-04-19
Classified by FDA Center: 2024-05-08
FDA published: 2024-05-15
Recalling firm: SUN PHARMACEUTICAL INDUSTRIES INC
Firm location: Princeton, NJ

Drug identification

Brand name(s): AMPHOTERICIN B
Generic name(s): AMPHOTERICIN B
Manufacturer(s): Sun Pharmaceutical Industries, Inc.
NDC(s): 62756-233
Route(s): INTRAVENOUS

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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