Testosterone Cypionate Injection
FDA Recall NDC 52536-625
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Testosterone Cypionate (NDC 52536-625). A significant event, classified as Class II, was initiated on Feb 15, 2023 by Wilshire Pharmaceuticals. The reported reason for this action was: "cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Feb 15, 2023
Apr 12, 2023
a) 16,471 vials; b) 43,096 vials
Recall Profile & Regulatory Data
Event ID
91710
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Azurity Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide
Termination Date
Dec 04, 2023
Product Description
Testosterone Cypionate Injection, USP, CIII, 200 mg/mL, packaged in: a) 10 mL multiple-dose vials (NDC 52536-625-10) and b) 1 mL single dose vials (NDC 52536-625-01), Rx only, Mfd for: Wilshire Pharmaceuticals, Inc., Atlanta, GA 30328.
Batch or Lot Expiration Information
Lot# 23804.034A, 23803.061A, Exp 9/2024
Affected Packages Involved in this Recall
52536-625-01Product
52536-625-10Product
Class III Terminated
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
Sep 27, 2019
Nov 06, 2019
67934 units
Recall Profile & Regulatory Data
Event ID
83959
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Arbor Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the US
Termination Date
Feb 02, 2021
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
Batch or Lot Expiration Information
Lot# 23803.002B, Exp 07/2020; 23803.005A, Exp 01/2021
Affected Packages Involved in this Recall
52536-625-01Product
52536-625-10Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
