SUN PHARMACEUTICAL INDUSTRIES INC: Drug Recall

Recall Details

Recall Number

D-0529-2023

Classification

Class III

Product Type

Drug

Recalling Firm

SUN PHARMACEUTICAL INDUSTRIES INC

Status

Terminated

Date Initiated

03/29/2023

Location

Princeton, NJ, United States

Voluntary/Mandated

N/A

Product Quantity

16,450 vials

Reason for Recall

Failed Impurities/Degradation Specifications: Above the specification limits yielded for related substance norepinephrine sulfonic acid impurity during routine product monitoring.

Product Description

Norepinephrine Bitartrate Injection, USP, 4 mg/4 mL* (1 mg/mL), 4 mL Single-dose Fliptop Vial (NDC 47335-615-40); packaged in 10 x 4 mL Single-dose Fliptop Vials per carton (NDC 47335-615-44); Rx only, Manufactured by: Gland Pharma Limited, Hyderabad-502307 India; Distributed by: Sun Phamaceutical Industries, Inc., Cranbury, NJ 08512.

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 →