Recall: D-0167-2020

Class III - Minor Violations

Class IIIClassification

2019-09-27Initiated

TerminatedStatus

Arbor Pharmaceuticals Inc.Firm

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

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

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.