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Recall Observatory FDA recall evidence

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

D-0703-2021

July 29, 2021

Class II

Product summary

Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Event
Event 88376
Status
Terminated
Classification
Class II
Quantity
2856 bottles
Official record key
drug-enforcement:D-0703-2021

Official wording

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

Code information: AVK1175A, exp 9/2023

Distribution pattern: Northstar Distribution Center 4853 Crumpler Rd. Memphis, TN 38141

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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