Testosterone Cypionate Injection, USP, CIII, 200 mg/mL, packaged in: a) 10 mL multiple-dose vials (NDC 52536-625-10) and
Summary
The FDA issued a Class II for Testosterone Cypionate Injection, USP, CIII, 200 mg/mL, packaged in: a) 10 mL mu by Azurity Pharmaceuticals, Inc.. Reason: cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials..
Details
Source
Drug Recall
External ID
D-0489-2023
Action Date
2023-04-12
Status
Terminated
Category
drug
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.
Lot/Code Info: Lot #23804.034A, 23803.061A, Exp 9/2024
Quantity Affected: a) 16,471 vials; b) 43,096 vials
Reason for Recall
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Distribution
US Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2023-02-15
Company
Wilmington, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 70 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Azurity Pharmaceuticals, Inc. has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Azurity Pharmaceuticals, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Azurity Pharmaceuticals, Inc. have FDA actions?
Azurity Pharmaceuticals, Inc. has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0489-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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