Why it was recalled
Lack of Assurance of Sterility
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 numbers, UPCs & expiration codes
Lot #: 179338, Beyond use date: 08/14/2024
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0630-2024
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 2, 2024
- FDA report date
- Aug 14, 2024
- Quantity
- 2,797
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- EMPOWER CLINIC SERVICES LLC
Original FDA data
Every field from FDA enforcement report D-0630-2024, exactly as published.
Show all FDA fields
- City
- Houston
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 95079
- Address
- 7601 N Sam Houston Pkwy W Ste 100
- Code information
- Lot #: 179338, Beyond use date: 08/14/2024
- Postal code
- 77064-3595
- Report date
- Aug 14, 2024
- Product type
- Drugs
- Recall number
- D-0630-2024
- Classification
- Class II
- Recalling firm
- EMPOWER CLINIC SERVICES LLC
- Product quantity
- 2,797
- Termination date
- Mar 28, 2025
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Aug 2, 2024
- Initial firm notification
- Letter
- Center classification date
- Aug 8, 2024