Venlafaxine Tablets…

Date

Aug. 18, 2021

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Terminated

Filed by

Sun Pharmaceutical Industries Inc

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

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

Distribution pattern

Northstar Distribution Center 4853 Crumpler Rd. Memphis, TN 38141

Quantity

2856 bottles

Codes and lots

AVK1175A, exp 9/2023

Recall started

July 29, 2021

Recall number

D-0703-2021

What should I do? Medicine recall: what to do

Source: FDA · Drug enforcement report, recall number D-0703-2021. The agency record governs; check it and the company before acting.