Drug recall D-0167-2020

Class III Terminated reported Nov 6, 2019

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

Reason for recall

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

Lots and codes

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

Recall details

Recalling firm
Arbor Pharmaceuticals Inc., Atlanta, GA
Quantity
67934 units
Distribution
Nationwide in the US
Type
Voluntary: Firm initiated
Recall initiated
September 27, 2019
Terminated
February 2, 2021

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