July 2021 FDA Recall Drug by Sun Pharmaceutical Industries Inc
D-0703-2021 - Presence of Forein Tablets/Capsules; Venlafaxine Tablets, USP 37.5 mg found in bottles labeled as Venlafaxine Tablets, USP, 50 mg

This Class II drug recall was voluntarily initiated by Sun Pharmaceutical Industries Inc on July 29, 2021 for the product Drug. The FDA reported the reason for recall as presence of forein tablets/capsules; venlafaxine tablets, usp 37.5 mg found in bottles labeled as venlafaxine tablets, usp, 50 mg. The product was distributed in Northstar Distribution Center 4853 Crumpler Rd. Memphis, TN 38141 and the recall is currently terminated.

Recall Number: D-0703-2021

Reason for Recall
Presence of Forein Tablets/Capsules; Venlafaxine Tablets, USP 37.5 mg found in bottles labeled as Venlafaxine Tablets, USP, 50 mg
Initiated
07-29-2021
Reported
08-18-2021
Quantity
2856 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88376
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Northstar Distribution Center 4853 Crumpler Rd. Memphis, TN 38141
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-08-2023
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# AVK1175A, exp 9/2023