Testosterone Cypionate Injection, 200 mg/mL, CIII, Rx Only, 5 mL Sterile Multiple-Dose Vial, Compounded by: Empower Phar
Summary
The FDA issued a Class II for Testosterone Cypionate Injection, 200 mg/mL, CIII, Rx Only, 5 mL Sterile Multipl by Empower Clinic Services, LLC dba Empower Pharmacy. Reason: Lack of Assurance of Sterility.
Details
Source
Drug Recall
External ID
D-0420-2025
Action Date
2025-05-21
Status
Ongoing
Category
drug
Product Description
Testosterone Cypionate Injection, 200 mg/mL, CIII, Rx Only, 5 mL Sterile Multiple-Dose Vial, Compounded by: Empower Pharmacy, 7601 N Sam Houston Pkwy W Ste 100, Houston, TX, 77064, Phone: (877) 562-8577, Compounding Date: 08/20/2024, Beyond Use by Date: 05/28/2025, Lot 202364.
Lot/Code Info: Lot #: 202364, Exp 5/28/2025
Quantity Affected: 8,230 vials
Reason for Recall
Lack of Assurance of Sterility
Distribution
USA Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2025-05-02
Company
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 35 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Empower Clinic Services, LLC dba Empower Pharmacy has 2 FDA actions in our database, including 2 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 (Empower Clinic Services, LLC dba Empower Pharmacy) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Empower Clinic Services, LLC dba Empower Pharmacy have FDA actions?
Empower Clinic Services, LLC dba Empower Pharmacy has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0420-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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