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Class III: unlikely to cause harmTerminated

Arbor Pharmaceuticals Testosterone Cypionate Injection Recall

Testosterone Cypionate Injection, USP, 2000 mg/10 mL, 1 mL Vial, Single-Dose, Rx only,…

Arbor Pharmaceuticals Inc. · Atlanta, GA

Risk level
Class III
Reported by FDA
Nov 6, 2019
Recall ID
D-0167-2020
Check your lot numberHow we source this data

Summary

Arbor Pharmaceuticals recalled Testosterone Cypionate Injection starting Sep 27, 2019. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0167-2020 on Nov 6, 2019. 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. Status: Terminated.

Why it was recalled

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

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

Lot numbers, UPCs & expiration codes

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

Where it was sold

Nationwide in the US

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0167-2020
Classification
Class III
Status
Terminated
Recall initiated
Sep 27, 2019
FDA report date
Nov 6, 2019
Quantity
67934 units
Recall type
Voluntary: Firm initiated
Recalling firm
Arbor Pharmaceuticals Inc.

Original FDA data

Every field from FDA enforcement report D-0167-2020, exactly as published.

Show all FDA fields
City
Atlanta
State
GA
Status
Terminated
Country
United States
Event ID
83959
Address
6 Concourse Pkwy Ste 1800
Code information
lot# 23803.002B, Exp 07/2020; 23803.005A, Exp 01/2021
Postal code
30328-5353
Report date
Nov 6, 2019
Product type
Drugs
Recall number
D-0167-2020
Classification
Class III
Recalling firm
Arbor Pharmaceuticals Inc.
Product quantity
67934 units
Termination date
Feb 2, 2021
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
Voluntary / mandated
Voluntary: Firm initiated
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
Distribution pattern
Nationwide in the US
Recall initiation date
Sep 27, 2019
Initial firm notification
E-Mail
Center classification date
Oct 30, 2019

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0167-2020, published Nov 6, 2019. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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