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Recall Observatory FDA recall evidence

Drug product

Testosterone Cypionate Injection, USP, 2000 mg/10 mL, 1 mL Vial, Single-Dose, Rx only, Mfd. for: Wilshire Pharmaceuticals, Inc. Atlanta, GA 30328. NDC 52536-625-01

D-0167-2020

September 27, 2019

Class III

Product summary

Firm
Arbor Pharmaceuticals Inc.
Event
Event 83959
Status
Terminated
Classification
Class III
Quantity
67934 units
Official record key
drug-enforcement:D-0167-2020

Official wording

Reason: Labeling:Label Mix-up: Shipper Carton labelled Testosterone Cypionate Injection, USP, 200mg/mL, 1 ml single-dose vials, found to contain shelf cartons labelled as Testosterone Cypionate Injection USP, 200mg/mL, 10 ml multi-dose vials which contain Testosterone Cypionate Injection USP, 200mg/mL,1mL single-does vials

Code information: lot# 23803.002B, Exp 07/2020; 23803.005A, Exp 01/2021

Distribution pattern: Nationwide in the US

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling:Label Mix-up