D-0167-2020 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- November 6, 2019
- Initiation Date
- September 27, 2019
- Termination Date
- February 2, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 67934 units
Product Description
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 Pattern
Nationwide in the US
Code Information
lot# 23803.002B, Exp 07/2020; 23803.005A, Exp 01/2021