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Recall Observatory FDA recall evidence

Drug product

BusPIRone Hydrochloride Tablets USP, 7.5 mg, 30-count bottles, Rx Only, Repackaged By: NOrthwind Pharmaceuticals, Indianapolis, IN 46203. NDC 51655-511-52

D-0549-2023

March 16, 2023

Class II

Product summary

Firm
Northwind Pharmaceuticals LLC
Event
Event 91944
Status
Ongoing
Classification
Class II
Quantity
6 bottles
Official record key
drug-enforcement:D-0549-2023

Official wording

Reason: CGMP Deviations

Code information: Lot#: F117312201, Exp. Date 06/30/2024

Distribution pattern: Nationwide with the United States

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations