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
Product summary
- 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
Labeling:Label Mix-up