FDA recall D-0703-2021

SUN PHARMACEUTICAL INDUSTRIES INC · Class II · drug

Product

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

Reason for recall

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

Distribution

Northstar Distribution Center 4853 Crumpler Rd. Memphis, TN 38141

Key facts

Status
Terminated
Initiation date
2021-07-29
Report date
2021-08-18
Termination date
2023-06-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0703-2021