February 2023 FDA Recall Testosterone Cypionate by Azurity Pharmaceuticals, Inc.
D-0489-2023 - cGMP

This Class II drug recall was voluntarily initiated by Azurity Pharmaceuticals, Inc. on February 15, 2023 for the product Testosterone Cypionate. The FDA reported the reason for recall as cgmp. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0489-2023

Reason for Recall
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Initiated
02-15-2023
Reported
04-12-2023
Quantity
a) 16,471 vials; b) 43,096 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91710
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Azurity 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
US Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-04-2023
Product Description About Product Description
Full technical description of the product.
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

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