SUN PHARMACEUTICAL INDUSTRIES INC: Drug Recall

Recall Details

Recall Number

D-0582-2024

Classification

Class II

Product Type

Drug

Recalling Firm

SUN PHARMACEUTICAL INDUSTRIES INC

Status

Ongoing

Date Initiated

07/02/2024

Location

Princeton, NJ, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

2088 vials

Reason for Recall

CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltered bulk for decitabine for injection.

Product Description

Decitabine for Injection 50mg per vial, For intravenous infusion only Cytotoxic Agent, Sterile, Rx Only, Single-Dose Vial, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 47335-361-40.

Distribution Pattern

Nationwide in the USA

Other Recalls by SUN PHARMACEUTICAL INDUSTRIES INC

• Class III: Low Risk 01/27/2026
  This market withdrawal has been initiated in response to Out of Specification (OOS) results observed in in viscosity for Diclofenac Sodium Gel, 3%.
• 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 →