Estradiol Cypionate Injection Recalled Due to Lack of Sterility Assurance
Empower Pharmacy is recalling Estradiol Cypionate Injection due to lack of assurance of sterility. The recall affects 2,797 units distributed nationwide within the United States.
The agency’s classification
FDA (Drugs): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This recall involves a risk-of-harm product (injectable drug without sterility assurance) with no reported illnesses or injuries, meeting the High severity threshold per the rubric. The potential for serious bacterial or fungal infections from non-sterile injectable medications justifies the assessment.
Plain-English summary
Empower Pharmacy is recalling Estradiol Cypionate Injection, 10mg/mL, supplied in 5mL sterile multiple dose vials. The affected lot number is 179338, with a beyond-use date of August 14, 2024. A total of 2,797 units were distributed nationwide within the United States.
The recall was issued due to lack of assurance of sterility. Estradiol Cypionate Injection is a prescription medication intended for intramuscular or subcutaneous use. Sterility is a critical quality requirement for injectable medications to prevent serious infections.
Healthcare providers and patients who have received this medication should contact their healthcare provider immediately. Do not use any remaining doses from the recalled lot. Patients should discuss treatment options and alternative medications with their healthcare provider. The FDA assigned recall number D-0630-2024 to this recall.
The recalled product
- Product
- 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
- Manufacturer
- EMPOWER CLINIC SERVICES LLC
- Category
- Drug — Injectable Hormone
- Affected units
- 2,797
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 179338
- Beyond use date: 08/14/2024
Distribution
Distributed nationwide across the United States.
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