Skip to content
Recall Observatory FDA recall evidence

Drug product

Tadalafil Tablets, USP 20 mg, packaged in a) 6-count bottles (NDC 51655-473-87), and b) 15-count bottles (NDC 51655-473-54), Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203.

D-0553-2023

March 16, 2023

Class II

Product summary

Firm
Northwind Pharmaceuticals LLC
Event
Event 91944
Status
Ongoing
Classification
Class II
Quantity
a)164 bottles; b) 198 bottles
Official record key
drug-enforcement:D-0553-2023

Official wording

Reason: CGMP Deviations

Code information: a) Lot #: F113892002, Exp. Date 08/31/2023; F113892201, Exp. Date 11/30/2023 b) Lot #: F113892001, Exp. Date 08/31/2023; F113892202, Exp. Date 11/30/2023; F113892203, Exp. Date 12/31/2023

Distribution pattern: Nationwide with the United States

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations