SUN PHARMACEUTICAL INDUSTRIES INC: Drug Recall

Recall Details

Recall Number

D-0703-2021

Classification

Class II

Product Type

Drug

Recalling Firm

SUN PHARMACEUTICAL INDUSTRIES INC

Status

Terminated

Date Initiated

07/29/2021

Location

Princeton, NJ, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

2856 bottles

Reason for Recall

Presence of Forein Tablets/Capsules; Venlafaxine Tablets, USP 37.5 mg found in bottles labeled as Venlafaxine Tablets, USP, 50 mg

Product Description

Venlafaxine Tablets, USP 50 mg*, 100 Tablets Manufactured for Northstar Rx LLC Memphis, TN 38141 Manufactured by: ALKALOIDA Chemical Company Zrt. 4440 Tiszavasvari, Kabay Janos u.29.Hungary. Product of India NDC 16714-657-01

Distribution Pattern

Northstar Distribution Center 4853 Crumpler Rd. Memphis, TN 38141

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 →