September 2019 FDA Recall Testosterone Cypionate by Arbor Pharmaceuticals Inc.
D-0167-2020 - Labeling

This Class III drug recall was voluntarily initiated by Arbor Pharmaceuticals Inc. on September 27, 2019 for the product Testosterone Cypionate. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0167-2020

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
Initiated
09-27-2019
Reported
11-06-2019
Quantity
67934 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83959
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Arbor Pharmaceuticals Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the US
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-02-2021
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

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

Affected Packages Involved in this Recall

52536-625-01 Testosterone Cypionate
52536-625-10 Testosterone Cypionate