SUN PHARMACEUTICAL INDUSTRIES INC: Drug Recall

Recall Details

Recall Number

D-0770-2022

Classification

Class III

Product Type

Drug

Recalling Firm

SUN PHARMACEUTICAL INDUSTRIES INC

Status

Terminated

Date Initiated

04/01/2022

Location

Princeton, NJ, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

73,030 boxes

Reason for Recall

Subpotent Drug and Presence of Particulate Matter: low out-of-specification results obtained for assay and the presence of particulate matter.

Product Description

Cequa (cyclosporine ophthalmic solution) 0.09%, packaged in 6 pouches x 10 single-use vials (0.25 mL each) per box, Manufactured for Sun Pharma Global FZE by: Laboratoire Unither, ZI de la Guerie, F-50211 Coutances Cedex, France, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 47335-506-96

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 →