Empower Pharmacy, Estradiol Cypionate Injection, 10mg/mL, 5mL Sterile Multiple Dose Vial, For IM or SQ use only, RX only
Summary
The FDA issued a Class II for Empower Pharmacy, Estradiol Cypionate Injection, 10mg/mL, 5mL Sterile Multiple D by EMPOWER CLINIC SERVICES LLC. Reason: Lack of Assurance of Sterility.
Details
Source
Drug Recall
External ID
D-0630-2024
Action Date
2024-08-14
Status
Terminated
Category
drug
Product Description
Empower Pharmacy, Estradiol Cypionate Injection, 10mg/mL, 5mL Sterile Multiple Dose Vial, For IM or SQ use only, RX only, Compounded by: Empower Pharmacy 7601 N Sam Houston Pkwy W Ste 100, Houston, TX 77064
Lot/Code Info: Lot #: 179338, Beyond use date: 08/14/2024
Quantity Affected: 2,797
Reason for Recall
Lack of Assurance of Sterility
Distribution
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2024-08-02
Company
Houston, TX
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 59 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
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) 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 have FDA actions?
This is the only FDA action we have on record for EMPOWER CLINIC SERVICES LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0630-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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