SUN PHARMACEUTICAL INDUSTRIES INC: Drug Recall

Recall #D-0891-2023 · 05/30/2023

Class II: Risk

Recall Details

Recall Number: D-0891-2023
Classification: Class II
Product Type: Drug
Recalling Firm: SUN PHARMACEUTICAL INDUSTRIES INC
Status: Terminated
Date Initiated: 05/30/2023
Location: Princeton, NJ, United States
Voluntary/Mandated: N/A
Product Quantity: 12960 vials

Reason for Recall

Subpotent drug

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

Distribution Pattern

USA nationwide

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Class III: Low Risk 12/30/2025

Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
Class III: Low Risk 11/26/2025

Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.
Class II: Risk 10/28/2025

Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
Class II: Risk 10/28/2025

Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.

View all recalls by SUN PHARMACEUTICAL INDUSTRIES INC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.