FDA recall D-0167-2020

Arbor Pharmaceuticals Inc. · Class III · 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

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

Distribution

Nationwide in the US

Key facts

Status: Terminated
Initiation date: 2019-09-27
Report date: 2019-11-06
Termination date: 2021-02-02
Voluntary/Mandated: Voluntary: Firm initiated
Location: Atlanta, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0167-2020